Total 13 job vacancies by Roche Singapore Technical Operations, Pte. Ltd.

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The Position

• This position supports the implementation and optimization of an integrated operation and maintenance strategy of Utility Systems within RSTO, through close partnership with internal and external stakeholders, to support drug substances manufacturing operations.

Key Responsibilities

• Responsible for the day-to-day monitoring/operation and preventive/ad-hoc repair and maintenance of all utility and manufacturing equipment/systems including the calibration of instrumentation and electrical installation/equipment serving the entire manufacturing facility and the execution of all job orders on shift on a 7 days per week and 24 hours a day basis.
• Carries out work and job orders relating to routine, preventive and ad-hoc calibration, repair and maintenance of utility and process equipment, instrumentation and electrical installation.
• Perform first level troubleshooting and maintenance on shift.
• Able to support and provide handyman service
• Receive and top-up chemicals in Utilities RO Systems and Waste Water Systems
• Perform salt loading (manual and overhead hoist) and brine solution preparation.
• Perform movement of CIP 100, CIP 200, Caustic chemicals
• Perform shutdown and restart to Utilities Systems in accordance with safety and quality requirements, to support maintenance and project activities.
• Provides mechanical support to manufacturing, utility and engineering services during routine and shutdown maintenance work; and product switchover in support of plant operations.
• To actively participate and perform workplace 5S housekeeping, upkeep GMP Area facilities fitness standard, by cleaning and painting indoor and outdoor utilities equipment such as wastewater plant, water tanks, RO Skids, drain trenches, piping systems, etc.
• Carry out improvement projects on operations and cost savings
• Monitor facilities and utilities systems via BAS/PCS and attend to alarms.
• Carries out any other work and task as directed by SMEs/Engineers/Supervisor/Manager

Who You Are

Education Requirements

• Min. NTC 3 and Above (or equivalent relevant work experience) is preferred
• MOM accredited WAH course for Workers is preferred
• MOM accredited course of handling of chemicals and hazardous substances is preferred
• MOM accredited Confined Space Entrant is preferred

The Opportunity:

As the Head of MSAT, you will ensure the site’s Right to Operate and drive manufacturing excellence by providing technical support for safe, high-quality, and continuously improving production. Your responsibilities include monitoring, analyzing, optimizing, and validating ongoing operations, as well as resolving production issues. You will collaborate with internal and external partners to transfer, implement, validate, and maintain new and existing products/processes. This role reports to the Site Head.

As the Head of MSAT, you will be responsible for:
Leadership & People Management:

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Establish strategic goals and objectives and maintain full strategic responsibility for the MSAT organization.
• As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of the MSAT organization.
• Proactively promote positive Safety Culture and cGMP operating principles.

Technical:
● Ensure Right to Operate through compliance with cGMP and regulatory
requirements applicable to the department.
● Direct areas of responsibility:

• Validation: Own, execute and improve the validation program for equipment, processes, and cleaning, and ensure compliance with PQS and HA requirements. Represent Validation program during HA inspections.
• Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with PQS and HA requirements.
• Tech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plant.
• Process Engineering: Establish oversight to ensure production is performed in conformance with license requirements, cGMPs, and global Health Authority expectations, and represent state of compliance during Health Authority inspections. Drive continually monitoring of process to implement continuous improvement process.
• Manufacturing Support: Provide technical support to manufacturing organization that includes process and product monitoring, master data and documentation management, compliance to Roche quality systems, and other readiness operational support activities.
• For specific sites: Pilot Plant Operations: Build and maintain pilot plant operations to support Make-Assess-Release activities, tech transfers, and continuous improvement of the production plant. Launch and PTD partner.

● Operate as one network: Partner with global MSAT teams and network peers at other manufacturing sites to share and adopt best practices across the network that drive continuous improvement in all technical aspects of production.
● Serve as a core member of the relevant Technical Council, provide site contributions to network technology roadmaps, ensure funding and execution of assigned projects on the respective site level.

Safety, Health & Environment:
● Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
● Implement, enforce and take ownership on all RSTO’s Safety, Health & Environmental (SHE) requirements and initiatives within his/her areas of responsibilities.
● Ensure all employees are competent and provided with the necessary tools and equipment to work safely and without health risks.
● Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:
● Embody PT lean leadership principles and methods while fostering a continuous improvement mindset.

Who You Are:

• Degree required in (Science or Engineering) discipline or equivalent with a minimum 17 or more years’ of related working experience or equivalent holders with combination of education and relative work experience is preferred.
• 6 or more years of people management experience in managing direct and indirect of workforce (>20 individuals) is preferred.
• 4 or more years’ relevant engineering or project management experience in the pharmaceutical industry and/or a cGMP environment is preferred.
• Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing.
• Expert knowledge of clean room or classified area design/requirements with deep process, equipment, automation, validation and technical knowledge.
• Possesses strong verbal and written communication skills and the ability to influence at all levels to build trustful and effective relationships.
• Able to think strategically and translate strategies into actionable plans.
• Takes responsibility, drives results, and achieves expected outcomes.
• Additional requirements may be specified by site and local needs.

Who We Are

Global Supply Chain (PTS) connects across the organization to ensure a reliable supply of our innovative medicines to patients. The external landscape continues to evolve and Roche's product portfolio has never been more dynamic so we are evolving our operating model/ the way we work to address these challenges. This includes building new capabilities, smarter and more sustainable use of our internal & external networks and resources and leveraging digital and new technologies. Come and join us to transform the customer and patient experience!

Role Purpose

The Customer Insights Lead is responsible for ensuring that the voice of the customer is factored into Supply Chain business decisions and strategies. The Customer Insights team is responsible for providing unbiased, objective, expert strategic insights by analyzing diverse data, to optimize supply chain design and enhance operations for more efficient and sustainable service to the patient. The team works in collaboration with the cross-functional parts of the organization (PT, PI, GPS, Diagnostics, etc…) to develop customer-centric solutions to bring value to the healthcare ecosystem and ultimately better outcomes for patients.

The Customer Insight lead also plays a crucial role as a strategic partner to the Regional SC teams to enable the sensing of the customers in the markets and support the transformation of insights into actionable business recommendations.

Your responsibilities:

• Developing and implementing a comprehensive customer insights strategy aligned with organizational goals
• Developing customer insights capabilities to enable customer centricity and support the change management process & deployment at scale led by SC business partners
• Understanding needs of future pipeline products, using this to coordinate efforts locally and regionally to meet these needs and launch coordination activities of new products within the market
• Defining key indicators to measure the effectiveness of customer insights initiatives
• Leading the analysis of customer data, leveraging statistical methods, data analytics tools, and other relevant techniques
• Interpreting complex data sets to identify trends, patterns, and actionable insights
• Collaborating with cross-functional teams, including global and regional SC teams, commercial, product development, quality and customer service, to integrate customer insights into decision-making processes

Your profile:

• You have a Bachelor's degree (preferably in science, engineering, or a business discipline); an MBA, PhD or other graduate- or post-graduate-level degree is an asset with 6 - 8 years' strategic consulting or related experience, including an emphasis on strategic analytics and insights, knowledge of strategic market research, competitive intelligence and business forecasting
• Your global bio/pharmaceutical experience is strongly preferred
• You have understanding and experience of business analysis techniques, processes and tools (incl. Visual business intelligence tools, SQL, etc…)
• You have a deep understanding of the external environment (healthcare setup, regulation, providers) and customer / patient segments and needs with strong business acumen
• You are outcome-based, solution-oriented, and show an enterprise-thinking mindset as well as strong analytical capabilities and skills and the ability to derive meaning from such analyses
• Effective interpersonal skills for stakeholder engagement, cross-teams collaborations and cross-organization communications, with a fluent English

Mindset

We're looking for people with a growth mindset to bring curiosity and new possibilities to the way the end to end supply chain can meet the needs of patients. In line with the Roche Operating Principles we put patients first always and look at how we can redesign our supply chain solutions to serve them in a way that makes an impact now but is also sustainable for the future.

1) General

a. Department: Quality

b. Reports to: MQA Team Leader

2) Purpose

● Provide QA oversight for RSTO to ensure that investigational medicinal products (IMPs) and commercial medicinal products are manufactured in accordance with global Roche, Pharmaceutical Quality System (PQS) and local site requirements.

● Responsible for escalation of quality issues following the criteria defined in current governing documents

● Support and/or perform routine “Make, Assess, Release” operations to meet targets and timelines

● Participate in the design and implementation of department and cross-functional initiatives

● To undertake additional responsibilities as required by Quality Management to meet business needs.

3) Key Responsibilities

Technical and Functional:

● Perform batch record, batch reports, logbook, cGMP documents and audit trail review to ensure quality of product, compliance to Roche requirements and on-time batch disposition per defined adherence to lead time

● Perform the following activities with QA oversight in accordance with Health Authority, Roche site and global PQS requirements:

- Provide guidance on categorization of unplanned events

- GMP area, Utilities and equipment release

- Execute Periodic Floor Walk

- Review Environmental Monitoring and Clean Utility Trend Control Strategies

- RSTO site Environmental Monitoring, Clean Utility Trend and Pest Control Reports approval

- Annual Audit of QC Controlled Print Documents

● Perform assigned tasks and manage competing priorities while meeting timelines to achieve company goals and department objectives

● Perform Change control assessment

● Perform Like to Like Assessments

● Notify Senior Management of potential quality, regulatory and compliance issues

● Support regulatory inspections and partner audits

● Serve as lead for Quality initiated programs

● Serve as trainer for core role specific activities

- Prepare training materials and conduct training on MQA-related procedures and processes as required

● Work alongside MQA Supervisor/ Manager in the following manner:

- Foster positive team environment by being inclusive while appreciating individualism

- Represent MQA in cross-functional meetings and discussions

- Serve as MQA subject matter expert (SME) during HA audits

Safety, Health & Environment:

· Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.

· Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

· Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

4) Qualifications

· Degree in Life Sciences or Engineering discipline or equivalent

· 1 to 5 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience

· Related working experience in a biotech or pharmaceutical operating environment is preferred

· Good knowledge of quality systems and QA principles, practices and standards for the pharmaceutical industry

· Strong knowledge of cGMP and GDP relevant to the pharmaceutical industry

· Able to make sound decisions on quality matters

· Demonstrated excellent organizational and planning skills in managing priorities

· Meticulous, systematic and of an analytical mind

· Good interpersonal, oral and written communication skill

· Proactive team player

· Proven ability to work well under pressure

· Flexible in work hours (including shift work) to meet business objectives

Purpose

Roche is a global pioneer & leader in Personalized Healthcare. We provide breakthrough differentiated medicines and diagnostic tests using expertise in Science, Technology and Data so that people can live better lives. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. The rapid digitalization of healthcare fuels an accelerated transformation in our industry. This change requires leaders who are entrepreneurial, who foster innovation & inspire teams to take risks, learn and progress quickly.

Your Opportunity

Regional Finance Development Program identifies top early-in-career talent and accelerates their development across APAC countries and across different parts of the business, enabling them to be key contributors to our company’s ambition and purpose, “Doing now what patients need next”.

Recognizing the central importance of experiential learning and development, Regional Finance Development Program provides a platform to strengthen a broad regional network and to gain experience and skills in different areas that will be vital for a career in Finance. We want you to reach your full potential by stretch assignments, doing rotations in different exciting roles. You will be part of transforming Finance and making it ready for the future.

What we offer you
The opportunity to build skills and capabilities across Finance in a variety of functions in APAC, roles, projects and locations during a 2 years time period. From Affiliate to Roche Services & Solutions (RSS), from Pharmaceuticals to Diagnostics. Post program, you are fully empowered to assess opportunities and decide on your further career with Roche. Mobility support is provided wherever that’s needed. Inspiring peers and thought leaders, and broad personal support by your Program Manager, a Rotation Manager, and a Senior Leader Mentor. Lifelong learning is part of our strategy; you will receive on-the-job training, formal leadership & self-directed learning, and will learn through targeted mentoring & coaching, and other networking resources.

Your Profile
● You bring a diverse perspective and you are ready to collaborate for impact. You are intrigued to work at the confluence of Finance, Science and Technology. You thrive in a collaborative work environment which enables teams to achieve beyond the sum of their parts. You understand that everyone leads, irrespective of hierarchy. As a fast learner, you proactively drive outcomes, integrate well into different cultures, teams and business settings. As a member of the Roche Finance community, you will embrace entrepreneurial spirit, enterprise thinking, inclusive collaboration and continuous learning. You are keen to build capabilities as a Finance professional to generate business outcomes. To be a successful candidate, you fulfill all of the following requirements:
● Excellent academic profile: Bachelors in Business Administration, Finance, accounting or any other related degree which has a Finance major or speciality, CFA/MBA/CIMA preferred
● Between 1-3 years of working experience with a focus in Finance, Healthcare Industry, consumer goods, Tech or Consulting with an exposure to projects related to innovation in digital or advanced analytics technologies
● Have a structured problem-solving and strategic analytical and agility skills

● Simplifying complex information into clear, synthesized insights as basis for decision making at all levels of the organization
● Excellent communication and influencing skills which enable collaboration in local and global networks
● Be passionate about driving adoption of new technologies, including AI, machine learning and RPA to provide financial transparency, drive productivity and derive insights
● Be comfortable collaborating in self-managed, cross-functional teams
● Be a team player and your personal qualities match our values of integrity, passion and courage
● Have a global mindset and think beyond boundaries with a high degree of regional/global mobility during and after the program
● Show strong leadership potential and have the ambition to take on a leadership position in finance in the near future
● Have an entrepreneurial spirit and foster a culture of business innovation

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Job Overview:

The Process Automation group is responsible for the equipment-related functionality configurations of the Process Controls Systems (PCS), Building Automation Systems (BAS), and a number of GMP and non-GMP Programmable Logic Controllers (PLC) skids. In addition, the group is responsible for the development and maintenance of Manufacturing Execution System (MES) recipe objects and master data.

This role is part of a team of Automation Engineers handling all process and utilities related aspects of the said systems, which includes but not limited to software and hardware configurations, associated interface with equipment and instrumentation, and Computer System Validation (CSV).

Key Responsibilities:

Under Supervision/Guidance from Automation Engineer (Senior / Associate Principal), trainee shall perform the following:

• Primarily responsible for the equipment-related functionality configurations of the PCS. Additionally, may be required to support equipment-related functionality configurations of the BAS and a number of PLCs.
• Support basic configurations of MES recipe objects and master data.
• Be capable of troubleshooting issues related to equipment and automation systems independently.
• Supporting evaluation of process discrepancies, developing corrective actions, and implementing corrective actions.
• Perform commissioning and qualification activities for automation systems.
• Collaborate with other functional teams such as Manufacturing, Quality, Engineering and other functions of MSAT on cross-functional projects and responsibility.
• Adhere to the requirements specified in Automation related Roche’s quality policies/quality standards or related SOP.
• Adopt Roche’s good engineering practice documents as guidance documents when performing the work function.
• Provide 24x7 support when needed.
• Flexible work arrangements will be in accordance with current site policies and practices.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Implement, enforce and take ownership of all RSTO’s Safety, Health & Environmental (SHE) requirements and initiatives within his/her areas of responsibilities.
• Ensure all employees are competent and provided with the necessary tools and equipment to work safely and without health risks.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while fostering and advocating a continuous improvement mindset and culture throughout the organization, by encouraging experimentation and learning.

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Job Overview:

This position supports the life cycle management program for all site equipment, facilities and utility system.

Key Responsibilities:

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
• Support a strong Engineering and Maintenance Safety Culture that encourages taking the right amount of time to perform each task safely.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Reliability Engineering:

• Support reliability improvement strategy.
• Proactively analyze plant reliability & downtime data to identify current & potential defects working in collaboration with Maintenance & Utilities Operations, Quality, Technology & Manufacturing.
• Support optimization of the application of preventive and predictive maintenance in order to achieve the right maintenance strategy & techniques for our manufacturing process equipment & site utility systems without compromising safety or compliance.
• Support data analysis for application of predictive Maintenance (PdM) methods such as oil analysis, thermography, vibration analysis, etc.
• Support analysis and compilation of reliability tools, equipment historical data, predictive technologies, and industry best practices to assist in determination and implementation of optimum equipment performance, maintenance strategies, and work processes. This includes supporting the development and analysis of criticality of equipment, maintenance strategy and spare parts.
• Assist in root cause analysis of reliability defects and verification of solution effectiveness
• Support Failure Modes and Effects Analysis (FMEA) on process and utility equipment and systems.
• Identify trends and make recommendations based on data.
• Support optimization of performance (reliability, maintainability & availability) of our systems and cost effectiveness of reliability programs. This includes supporting the application of condition based preventive maintenance strategies.
• Analyze routine maintenance practices and assist in initiation and implementation of maintenance process changes that increase equipment and system uptime.
• Document system reliability issues and support equipment design change recommendations including supporting the evaluation of the cost benefit of changes to improve reliability.
• Assist in obsolescence tracking and management.
• Assist with new equipment purchase specifications, purchase decisions and installation qualification criteria.
• Provide support and input for the Asset Management Strategy.
• Interact with client groups, service providers, existing maintenance management, and Roche Network functions to leverage and support optimization of maintenance support resources, programs and practices.
• Assist MRO in the retention and archival of completed forms and documentation
• Complete all required in-house training in a timely manner
• All other duties and activities as directed by Supervisor

Qualifications

• Degree/Diploma in Engineering, preferably with knowledge of operation & maintenance of production & utilities systems.
• Knowledge of cGMP concepts and guidelines.
• Experience in biopharmaceutical production facility a plus.
• Knowledge of Reliability Management systems & various Predictive Maintenance methods preferred.
• Knowledge of FMEA, RCA, 5S, Lean Six Sigma, methodologies preferred.
• Demonstrated good organizational and time utilization skills.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Key Responsibilities

• Responsible to ensure the completion of engineering maintenance and calibration work for the entire manufacturing facility.
• Troubleshoot and provide technical support to a team of maintenance and calibration specialists on shift to perform engineering maintenance and repair of facilities and manufacturing equipment in support of plant operations.
• Provide support to manufacturing, utility and engineering services during routine and shutdown maintenance work; and product change over in support of plant operations.
• Performs timely review and technical completion of work orders, initiate follow up work order and notification as required.
• Provide support to Project Engineering Team to deliver project within stipulated timeline and budget.
• Partner with Quality and UPE owner to ensure timely closure of UPE records and related follow up actions.
• Analyze/create preventive maintenance procedures and/or practices to comply with regulatory codes, specifications, standards and corporate guidelines for the safe, reliable and efficient operation of the plant to ensure validity, efficiency, maximum production equipment uptime.
• Work with Reliability team to establish predictive maintenance program for the facility such as Thermal Scanning (IR), Ultrasonic, Vibration Monitoring etc
• Increase the mean time between failure (MTBF) of equipment by identifying and eliminating the causes for recurring issues and to implement robust solutions.
• Partner with the Maintenance and Calibration team to reduce mean time to repair (MTTR).
• Assist with continuous improvement project (Kaizen) and initiate change request to optimize maintenance/calibration activities if required.
• Review engineering specifications and design modification proposals to improve reliability within cost and other performance requirements.
• Coordinate with MRO storeroom personnel to establish and maintain the proper stocking levels of parts and equipment required to provide maximum equipment uptime at the lowest possible costs.
• Carries out any other work and task as directed by Supervisor.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Qualifications (education/experience/knowledge/skills/competencies)

• Degree/Diploma in Mechanical, Marine, Electrical/ Instrumentation or Chemical Process Engineering with at least 1-2 years experience in pharmaceutical or chemical manufacturing will be desirable.
• Candidates with 1-2 years hands-on maintenance working experience in Pharmaceutical or Chemical manufacturing and experience in project start-up will be preferred.
• Strong background in Operation and Maintenance of equipment and instruments in the production and utility area will be preferred.
• Experience in setting up SAP Maintenance Program, spare parts store, project start-up environment and safety procedures/practices is an added advantage.
• Excellent computer skills including but not limited to CMMS software, spreadsheets and word processing software.
• Excellent analytical problem solving skills and persistence to resolve outstanding issues.
• Excellent inter-personal and communication skills, both written and verbal.
• Must possess the ability to work independently with adequate direction and guidance, and deliver projects/tasks on time and within budget.
• Must be team oriented and be able to work with members of the team.
• Strong customer service skills, attention to details, accurate and thorough.
• Strong concept of cGMP in area of Maintenance and Calibration.
• Willing to be scheduled to occasionally work after office hours in support of operations.

Carry out maintenance activities such as:

• Servicing of equipment such as centrifugal pump, diaphragm pump, replacement of mechanical seal, pump alignment, rigging & lifting.
• Perform repairs and other maintenance activities to specified specs and standards per procedure.
• Able to perform predictive maintenance and data collection for field equipment
• Able to perform QC equipment maintenance and troubleshooting such as freezer and incubator.
• Attend to equipment breakdown and preventive maintenance on short notice during weekends/public holidays.
• Support equipment inspection with vendor representative on tanks, column, pipelines and centrifuge as per RSTO Visual Inspections standards.
• Repair and replace damaged parts to bring equipment back into service timely to support continuous production planning.
• Perform minor piping modification and rebuild of MRO spare part.
• Perform polishing and passivation of vessel internal surfaces according to RSTO procedure.
• Maintain all machine shop tools and equipment such as, and not limited to, welding set, working tooling, lifting gear.
• To actively participate and perform workplace 5S housekeeping.
• Able to contribute and implement Safety Improvement Ideas for CI projects works together with System/Equipment Engineers.
• Perform tasks as defined in the Maintenance Work Orders for assigned equipment or system.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Job Qualifications:

The following trainings shall follow the latest applicable WSH regulations

• Scissor Lift/Vertical Personnel Platform - Operator
• Confined Space Operation - Worker
• Work at Height – Worker

Job Requirements:

• Willing to perform shift hours as required.
• Minimum of 3 years working experience, including GMP and Pharmaceutical environment
• Proficiency in spoken and written English.
• Computer literate on Microsoft Office, Email operating system, CMMS software.
• Working experience in handling of hazardous chemical.
• Working experience in basic welding and fabrication work.
• Preferred working experience in handling of Electro-polishing Equipment.
• Preferred experience in operating digital video scope.
• Preferred experience in handling homogenizer and centrifuge equipment.
• Preferred work experience in GMP and Pharmaceutical environment.
• Able to interpret P&ID, LOTO mark-up drawings and perform physical Energy isolation processes.
• Able to perform confine space vessel related work.
• Able to support night shift and outside office hours as assigned by RSTO or Task Supervisor.
• Willing to accept 1-Year contract basis.

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Key Responsibilities

• Support the Biochemical Manufacturing Department by working effectively within the group to meet department goals and objectives.
• Responsible for completing assigned tasks which may include preparing small equipment, cleaning and sterilizing vessels, preparing solutions,monitoring and operation biochemical processing equipment, raw materialssampling, dispensing and environmental monitoring sampling and maintain housekeeping of the areas while adhering to Safety, cGMP and Biochemical Manufacturing guidelines.
• Assigned tasks must be prioritized and work must be documented per approved manufacturing formulae.
• Troubleshoot equipment and process problems.
• Support process improvement efforts.
• Operate computers for process control and data entry.
• Participate in staff and shift change meetings and work closely with other shift personnel and external support groups.
• Ensure all assigned tasks are performed as per safety requirements. Report safely incidents and near misses on a timely basis and support SHE in incident investigation.
• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses, and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Qualifications

• Fresh Graduate with degree in Life Sciences or Engineering discipline or Diploma or NITEC or equivalent holders.
• Diploma holders with at least 3 years of experience. NITEC or equivalent holders with 7 years of experience. Biologics experience is a plus.
• Must possess good problem solving, interpersonal communication and team skills.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Job Overview

Ensure the completion of maintenance tasks and provision of technical support while in full compliance with current Good Manufacturing Practices (cGMP), Safety, Health and Environment (SHE) and Quality policies and standards.

Key Responsibilities

• Responsible for coordinating all external and in-house calibration, maintenance and repair of all utilities and manufacturing equipment/systems serving the entire manufacturing facility and the execution of all job orders by external vendors.
• Responsible for raising purchase requisition for vendors' services through local (Computerized Maintenance Management System) CMMS system.
• Establish good relationship with stakeholders not limited to external vendors/partners, manufacturing, utility, maintenance team.
• Provide technical support to calibration technicians on shift to perform calibration, maintenance and repair of facilities and manufacturing equipment in support of plant operations.
• Provide support to manufacturing, utility and engineering services during routine and shutdown maintenance work; and product change over in support of plant operations.
• Performs timely review and technical completion of work orders, initiate follow up work order and discrepancy notification as required.
• Provide technical expertise in Maintenance, Electrical and Instrumentation to Project Engineering Team and deliver project within stipulated timeline and budget.
• Provide support in the creation or amendment of preventive maintenance or calibration procedures and/or practices to comply with regulatory codes, specifications, standards and corporate guidelines for the safe, reliable and efficient operation of the plant to ensure validity, efficiency and maximum production equipment uptime.
• Increase the mean time between failure (MTBF) of equipment by identifying and eliminating the causes for recurring issues and to implement robust solutions.
• Partner with the Maintenance and Calibration team to reduce mean time to repair (MTTR).
• Implementation of continuous improvement project (Kaizen) and initiate change request to optimize maintenance/calibration activities if required.
• Provide support to the Maintenance and Calibration team during health authority inspections.
• Knowledge in BAS/PCS/PLC/HMI.
• Knowledge in Maintenance and Calibration Processes and Standards.
• Knowledge in Analytical and Laboratory Instrumentation.
• Participate in Root Cause Analysis (RCA's) to identify potential root cause and follow up on all corrective actions and preventive actions.
• Working knowledge in Permit to Work System, Job Safety Analysis (JSA), Risk assessment (including RCA, HAZOP, FMEA), Confined Space System, Work At Height

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Qualifications (education/experience/knowledge/skills/competencies)

• Degree/Diploma in Mechanical, Marine, Electrical/ Instrumentation or Chemical Process Engineering with at least 1-2 years experience in pharmaceutical or chemical manufacturing.
• Candidates with 1-2 years hands-on maintenance working experience in Pharmaceutical or Chemical manufacturing and experience in project start-up will be preferred.
• Strong background in Operation and Maintenance of equipment and instruments in the production and utility area will be preferred.
• Experience in setting up SAP Maintenance Program, spare parts store, project start-up environment and safety procedures/practices is an added advantage.
• Excellent computer skills including but not limited to CMMS software, spreadsheets and word processing software.
• Excellent analytical problem solving skills and persistence to resolve outstanding issues.
• Excellent inter-personal and communication skills, both written and verbal.
• Must possess the ability to work independently with adequate direction and guidance, and deliver projects/tasks on time and within budget.
• Must be team oriented and be able to work with members of the team.
• Strong leadership and customer service skills, attention to details, accurate and thorough.
• Strong concept of cGMP in area of Maintenance and Calibration.
• Willing to be scheduled to occasionally work off shift hours in support of operations.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Job Overview:
This position supports facilities operations, optimization and improvement initiatives in facilities management operations, programs and site procedures, with the facilitation of cross-functional collaboration.

Key Responsibilities:
● Support F&E contract reviews in collaboration with F&E internal stakeholders
● Be a central contact for timely Shopping Cart and Purchase Order creation using the appropriate platform.
● Participate in discussions and site visits to identify areas of Continuous Improvements and bring about value enhancements to F&E operations.
● Perform critical thinking/review for harnessing new technologies and methodologies to bring about facility operation enhancements to meet the needs of RSTO community and manufacturing operations.
● Support Facilities operations in delivering site services, such as gathering and analyzing user data, performing Gemba walks, monitoring key conditions and deliverables for supporting Make-Assess-Release activities.
● Manage GMP/Non-GMP change management activities and documentation for improvement initiatives in collaboration with various site functional groups.
● Support engagement communications and activities to internal stakeholders.
● Use of Visual Management tools to provide visibility of project/program status updates.
● Support in reviewing project documentation in adherence to Roche Engineering Manual Lite for expense/capital projects.
● Assist in project coordination and site inspection with internal and external project members.
● Perform any other tasks as assigned by the supervisor.

Safety, Health & Environment:
● Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
● Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:
● Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Qualifications & Experience
● Diploma/ Degree in Engineering or Science discipline is preferred.
● Fresh graduates/ mid-career professionals who are switching out of other industries.
● Able to and preferably with experience working across different functions within an organization.
● Flexible and adaptable to work with various project teams and contractors on site.
● Able to work independently, manage multiple tasks/priorities and have good communication and organizational skills
● Excellent knowledge and experience in the use of MS Office tools.
● Have customer service skills, attention to details, accurate and thorough.
● Be self-motivated, able to lead and take initiative.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Job Overview:

• Perform routine and ad-hoc environmental monitoring (EM) of critical utilities such as HVAC/BSC/VLFH/HLFH, water systems, compressed air/gas system and personnel monitoring
• Lab testing of EM samples in accordance with cGMP regulations and Roche/Genentech standards.
• Support manufacturing operations by timely completion of testing and disposition.

Key Responsibilities:

Technical and Functional:

• Perform EM which includes HVAC/BSC/VLFH/HLFH monitoring, compressed gas, personnel monitoring, water and clean steam sampling in accordance to cGMP procedures.
• Perform testing and review of routine and non-routine environmental monitoring samples in accordance to the Standard Operating Procedures (SOP).
• Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
• Prepare EM trend graph periodically for trend data analysis.
• Operate laboratory autoclave and EM testing equipment.
• General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
• Perform daily checks in EM LIMS to ensure all assigned EM tasks are completed and/or tested on time.
• Initiate discrepancy record for EM action excursion, adverse trend and/or discrepant event.
• Carry out assignments / projects given by Supervisor. Deliver results per plans / schedules.
• Communicate all problems / issues timely to Supervisor.
• Suggest improvements to streamline / facilitate workflows.
• Participate in internal / external audits and regulatory inspections.
• Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
• Monitor and keep track of inventory stocks for laboratory consumables and items required.
• Perform sample receipt and storage of QC samples.

Leadership:

• Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives / goals, takes the initiative and proactively turn ideas into action – to make things happen.
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
• Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
• A team player and the willingness to cover other colleagues in continued support of the Micro / EM operations.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Key Interfaces:

• Other QC functions
• FEES / Utilities
• Manufacturing
• Warehouse
• Safety, Health and Environmental (SHE)

Qualifications:

Education

• Bachelor’s degree in a relevant science field or equivalent

Knowledge / Skills / Competencies:

• Demonstrate good verbal and written communication skills in English
• Independent, reliable and collaborative team player
• Able to follow written procedures.

Prepared to work overtime on weekday(s), weekend and/or Public Holiday and willing to perform shift duty if required