Total 7 job vacancies by 1061 Amgen Technology (Ireland) UC

Career Category

Job Description

The Manufacturing Process Technician at Amgen plays a crucial role in the operation and maintenance of manufacturing equipment. This individual is responsible for monitoring and adjusting manufacturing processes, troubleshooting any issues, and ensuring the quality of final products. They work in compliance with company policies and safety regulations.

Career Category

Job Description

Overview:

In this role, you will be responsible for leading investigations for Engineering and Validation deviations, along with being involved in applying process, quality, compliance, and analytical knowledge to complete the following:

- Ensure Non-conformance are triaged within the established goals and serve as a deviation owner for minor and major deviations.

- Initiates and manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs and EV’s, completing product impact assessments, prior occurrence reviews and authoring investigation reports.

- Own corrective /preventative actions and effectiveness verification.

- Update and maintain F&E procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

- Present investigations to regulatory inspectors and internal auditors. Provide back-room support during on-site regulatory inspections.

- Oversee F&E audit readiness activities and track tasks to completion. Represent F&E function at Site Inspection Steering Committee meetings.

- Generate Quality and Safety metrics for F&E function. Provide reports on quality and safety compliance.

- Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. improvements, compliance topics and change control GDEs

- Assist with generation and execution validation protocols and reports. 

EDUCATION

B.A. /B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.

EXPERIENCE

3+ years' experience in a similar role

COMPETENCIES/SKILLS

- Detailed technical understanding of manufacturing/engineering unit operations.

- Skilled in performance of GMP production operations

- Regulatory knowledge and interactions

- Ability to lead cross-functional teams

- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.

- Excellent organizational, technical writing and presentation skills.

- Good project management skills.

- Basic knowledge of control charting.

Career Category

Job Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The ADL site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people’s lives. Amgen is developing the capability to produce all of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally.

As a member of the Automation Projects Team, the role will support complex and challenging system automation initiatives and project delivery.

Key Responsibilities

• Responsible for supporting all tasks related to the automation system project lifecycle, from solution design to GMP qualification.
• Project management and execution of assigned projects including project prioritisation, resource management, status reporting and external communication.
• Working with various stakeholders to scope projects and ensure requirements are satisfied.
• Critically analysing system design, developing, and recommending continuous improvements in line with the latest technology and regulatory standards.
• Work in a collaborative manner within cross functional teams.
• Lead and support system improvements, development of detailed specification, engineering documents, and standard operating procedures.
• Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
• Solving complex problems, lifecycle management and operational excellence.
• Develop and manage change control requests per established SOPs and processes.
• Develop detailed specifications, engineering documents, system impact assessments, test protocols and standard operating procedures.
• Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Travel at various times may be required to support execution of projects.

Preferred Qualification and Experience

• Bachelor’s in electrical engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering with 5+ years’ experience in operations/manufacturing environment.
• Manufacturing automation experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities.
• Excellent control systems automation background focused specifically in design, installation, programming, validation and lifecycle maintenance of automated equipment.
• Experience programming and troubleshooting PLC (e.g. Allen Bradley, Siemens, B&R), SCADA (e.g. IFix, InTouch, Zenon), PCS (e.g. Rockwell Automation Platforms) and Batch Systems (e.g. Factory Talk Batch).
• Industrial Networking experience with ControlNet (CNET), DeviceNet, Profibus etc.
• Experienced in the use of Automation support tool such as RSLinx, RSNetworx, FactoryTalk AssetCentre, ThinManager and OSIsoft PI Data Historian.
• Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11.
• Working knowledge of network architecture technologies including TCP/IP, Routing, Switching, Network IDS/IPS, Active Directory, Domain Integration and Firewalls.
• Solid leadership, technical writing, and communication/presentation skills.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Experience in developing automation strategies for new product introduction and new technology deployment.
• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
• Ability to influence the development of business area strategy and Automation strategy where appropriate.
• Ensure application of corporate blueprint and standards using business drivers to local business needs and project requirements.
• Independent, self-motivated, organised and able to multi-task in project environments.
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
• Proficient in managing relationships with stakeholders, coordinating and collaborating with teams from different departments in order to achieve common goals.

Career Category

Job Description

Job Description Summary

The Manufacturing Process Technician reports to the Shift Manager and will be responsible for one or more of a number of roles relating to the manufacture of sterile parenteral drugs to include but not limited to operation and set up of manufacturing equipment, processing of parts and components for manufacturing, performing transactions in electronic systems such as EBR, LIMS, SAP etc. and cleaning and sanitization of production areas.

This job specification outlines the general responsibilities associated with the role of Manufacturing Process Technician on the Amgen Manufacturing Site. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.

Please note this is a Fixed Term Contract role for 24 months and successful candidates will be required to work a shift pattern.  Candidates must have previous aseptic experience.

Hiring Requirements:

• Manufacturing Process, Packing and Inspection Technicians are required to work a variety of shift patterns including days, 2, 3 and 4 cycle shifts.

• They will perform all operations with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements.

• They will be involved in problem solving and troubleshooting including initiation and documentation of investigations.

• They will be responsible for the performance of self-inspection Quality & Safety Audits within their functional area.

• They will be part of a learning and development program which will include annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process. They will be responsible for the cross training of other colleagues.

• They will be responsible for the use, review, revision and upgrade of operational documentation and peer review of operations.

• They will play a key role in the development of the manufacturing systems and will be responsible for continuous improvement initiatives. Proactively identifying operational improvement opportunities or process related issues including escalation & follow up with area Sr. Associate Tech Engineers for effective resolution and implementation.

• They will be champions for safe working practices and safety initiatives within their functional area.

• They will carry out any sampling, testing and inspections that may be required.  They will also carry out calibration and maintenance of test equipment.

• Contribute and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.

• They will carry out any other duty as may be designated by supervisor/ management from time to time.

Qualifications:

• Educated to Leaving Certificate standard or equivalent (minimum five passes including English and Mathematics required).

• A third level qualification in a relevant discipline would be an advantage.

• Applicants should have some relevant experience of operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.

• Be a results-oriented person with excellent organization, communication and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.

• Demonstrated ability to deliver to team, site and personal objectives.

• Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.

Preferred Skills:

Experience working with equipment utilised in the manufacture of parenteral products such as autoclaves, filling lines, formulation vessels plus:

•Good mechanical aptitude

•Excellent problem-solving skills

•Ability to work in a team environment and on one’s own initiative

•Experience working in Grade A/B area.

Career Category

Job Description

Specialist Quality Assurance

The Quality Assurance (QA) Specialist will be an active member of the ADL QA team.  The QA Specialist will be assigned to the Incoming Quality Assurance (IQA) functional area, which is responsible for the inspection and release of incoming primary and secondary packaging components and sampling of raw materials. The QA Specialist will report to a QA Senior Manager.

In addition to routine Quality Assurance duties, QA Specialists may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.

Incoming Quality Assurance Specialist Key Responsibilities

• Act as Quality point of contact for incoming inspection and sampling processes, providing advice to ensure all activities meet internal and regulatory expectations.
• Oversight of ADL and external Warehouse activities.
• Manage the introduction of new techniques and equipment to IQA, including method transfers, and validations
• Assume ownership and/or oversight of change control and Deviation/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Participate in product complaint investigations, as required.
• Provide training and advice to staff in relation to testing of components.
• Actively participate in audits and their preparation.
• Evaluate practices for compliance and operational excellence improvement on a continuous basis.
• Perform all activities in compliance with Amgen safety standards and SOPs
• Ensure all GMP compliance training is up to date before performing GMP activities and participate in training of new colleagues
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies, and procedures.

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience, and knowledge.

Basic Qualifications:

University degree - Engineering or Science related discipline preferred.

Relevant experience (8+ years) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications:

Excellent written and verbal communication skills

Experience working with dynamic cross-functional teams and proven abilities in decision making and influencing

Strong organizational skills, including ability to follow assignments through to completion

Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.

Career Category

Job Description

Primary Responsibilities:

The Senior Maintenance Technician will report to a Maintenance Manager and will work within the Filling, Lyophilisation or Inspection & Packaging maintenance teams with the primary responsibilities laid out below.  As the site expands, development opportunities may exist to transfer between teams and to gain experience with the equipment in each area of the plant mentioned above.

Equipment Maintenance

• Execute advanced maintenance activities on process equipment in accordance with standard operating procedures across multiple production and packaging facilities.
• Perform troubleshooting and equipment investigation works while assuring minimal impact to plant operations and in compliance with good maintenance practices, SOP’s and GMP requirements.
• Ability to work independently and as part of a team, taking responsibility for completion and handover of work, GMP documentation and ongoing maintenance of training qualifications.
• Demonstrated ability to participate in cross-functional teams to investigate non-conformances, deviations, and troubleshoot issues to establish root causes and corrective actions.

Projects and Continuous Improvement

• Support projects and start-up of new process plant, inspection or packaging equipment.
• Support process investigations, trials, machine upgrades and testing in conjunction with the wider engineering team.
• Assist with the development, execution, and support of the CQV (Commissioning, Qualification, Validation) process.
• Identify and implement improvement ideas to enhance equipment operation, reliability and the efficiency of maintenance programs.

GMP and Compliance

• Maintain high levels of aseptic compliance and housekeeping standards in manufacturing areas, workshops and training areas whilst operating as part of a cross functional team to support the plant.
• Demonstrated ability to self-maintain online and practical training or qualification status in compliance with site operating procedures and key area metrics.
• Ensure work is undertaken in a safe, compliant manner in accordance with legislative, site and corporate safety and quality procedures.

Documentation

• Ensure that maintenance documentation is completed accurately and in accordance with applicable procedures such as ALCOA+ principles.
• Develop, revise & review relevant technical documents (Maintenance SOP’s, Job Plans, P&IDs etc.) in conjunction with the broader Engineering support team.
• Familiarity with the purpose and use of CMMS systems, Electronic Batch Records and electronic logs.

Primary Knowledge and Education:

• Recognised apprenticeship in an electrical / mechanical craft.
• Leaving Certificate or equivalent (minimum five passes including English and Mathematics).
• Ability to read and understand mechanical drawings, technical manuals, electrical wiring schematics, layout drawings and P&ID’s.

Preferred Qualifications and Experience:

• Combined education, training and experience in mechanical / electrical maintenance, experience in a regulated manufacturing environment would be an advantage.
• Any relevant experience in an automated inspection and packaging environment would also be an advantage.
• Knowledge and experience working in a pharmaceutical or aseptic manufacturing facility.
• Knowledge of pneumatic, mechanical, hydraulic systems and ability to effectively perform associated maintenance activities on these systems.
• Knowledge and experience of working with electrical panels.
• Experience executing and documenting maintenance work in a computerised maintenance management system.
• Ability to interpret P&ID's, identify hazards, isolation points and inter-dependancies between services for LOTO purposes.
• Ability to work with minimum direction, identify issues and effectively communicate the status of equipment or tasks in a timely manner.

Career Category

Job Description

This role is accountable for the operational support and coordination of all

activities associated with installation and maintenance of equipment in Amgen datacenters, computer rooms and voice data equipment rooms, located at the Amgen Dun Laoghaire manufacturing site.

Responsibilities

• Coordinate and execute cable installations, hardware rack / stack installations, testing, and troubleshooting in compliance with Amgen datacenter procedures.
• Manage and perform power cycles, swap out failed components, handle storage media, and perform troubleshooting.
• Physically assist in moving and racking equipment.
• Support deployment of on-site datacenter physical infrastructure including Servers, Network devices, and Storage Area Networks.
• Work with IS teams to understand server and network hardware requirements with respect to power density, rack positioning, cabling, cooling, airflow containment and environmental consideration.
• Work with IS ticketing systems and datacenter information management tools
• Oversee the delivery of supporting MEP (mechanical, electrical, plumbing)
• Support the continuous improvement datacenter operations standards and procedures.
• Communicate with internal stakeholders on upcoming activities with potential impacts.
• Provide direction to internal and external consultants and third party service providers.