Total 2 job vacancies by 1001 Amgen Inc.

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Manufacturing Systems Engineer- BAS and Warehouse Systems

Live

What you will do

Let’s do this. Let’s change the world. In this role the Sr Automation Engineer for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Facilities & Engineering team responsible for providing maintenance leadership and technical expertise in support of safe and reliable facility infrastructure, facility equipment/systems, utility systems, and/or production suites, ensures systems operate within designed parameters within GMP assembly, packaging and warehouse operations. The area of responsibility may consist of multiple facilities, subject areas, or clients. All work to be completed to assure minimal impact to production while staying in sync with all cGMP guidelines and Amgen procedures.

• Strictly follow the company’s safety and cGMP policies and procedures.
• Determining Automation Systems specifications.
• Coordinating and leading contractors performing maintenance activities on managed systems.
• Maximo (CMMS) System Owner for Automation Locations and Assets
• Ensure preventive maintenance related to Automation Systems is in place using reliability engineering principles.
• Develop and maintain building control automation and automated warehouse systems applying Siemens and Allen Bradley Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Support functional area projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
• Lead/support technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.
• Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen’s goals
• Maintain Data Integrity Assessments with the current Amgen and Industry standards
• Collaborate with Amgen Plant network to improve the automation design for the site.
• Day-to-day Operational Support including:
• 24 x 7 Onsite/On Call: Day to Day Operational Support
• Trouble shooting Support to Site Operations
• Building and Warehouse Automation System Administration
• Automation System Operating Systems (OS) assessments and rollout
• Daily engineering work center team meetings
• Preventative and corrective maintenance
• Automation System spare parts management
• Drive true root cause investigations and resolutions by collaborating with equipment Vendors.
• Business Process Improvements including departmental Standard Operating Procedures (SOP) and Job plans for the area of responsibility to assure all maintenance operations are performed safely and reliably
• Provide subject matter expertise for automation-related expansion and or capital projects

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek will these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech or related technical subject area experience and 2 years of Automation experience

Or

Bachelor’s degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech or related technical subject area experience and 4 years of Automation experience

Or

Associate’s degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech or related technical subject area experience and 8 years of Automation experience

Or

High school diploma / GED and 10 years of Automation experience

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech or related technical subject area experience
• Extensive understanding and background in programming, design, installation, and lifecycle management of Automation design, experience in process control engineering and solving problems with GMP biopharmaceutical production facility equipment/systems, and integrating various OEM automation software and field instrumentation.
• Experience in an FDA (GMP) or comparable regulated environment preferably Pharmaceutical and/or Biotechnology industry
• Plant and applicable industry regulation knowledge / expertise
• Strong automation and/or systems capability with hands on experience in a technical role within a high-volume manufacturing environment
• Allen Bradley Automation SCADA and PLC Platform.
• Siemens SCADA and PLC Platform.
• Experience with RCM, TPM or other reliability centered concepts
• Ability to work multi-functionally, delivering technical solutions and implementing improvements.
• Knowledge of the project management cycle and how to support in the development/delivery of a project.
• Experience managing GMP facility cleaning and pest control programs
• Experience managing integrated service providers
• Solid leadership abilities and experience working in a team environment, embracing an interdependent working culture that delivers results
• Technical report writing and communication/presentation skills
• Data driven decision maker
• Ability to work to tight deadlines in a fast-moving environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Manufacturing Systems Engineer (Automation)

Live

What you will do

Let’s do this. Let’s change the world. As a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Automation team you will support B7 EPO Commercial Drug Substance plant operations This includes complex and challenging system automation initiatives that require understanding of various automation platforms, integration between multiple platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence.

Responsibilities include:

• Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA), ABB robotics, and Mitsubishi roller bottle machine.
• Lead/support technical root cause analysis, incident investigations, and trouble shooting on process control issues related to plant operations.
• Own change control records, CAPA records and deviations as it relates to Automation systems.
• Support functional area projects focused on improving process equipment, cleaning systems and utilities to ensure reliability of drug substance manufacturing facility.
• Lead and support new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen’s Ambitious goals.
• Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Support Review by Exception (RbE) functionality for all EPO systems that includes product Batch records, cleaning, and sterilization systems, Audit trail and version control systems.
• Collaborate with Amgen Drug Substance Plant network to enhance the automation design for EPO Drug Substance Plant Operations
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.
• Day-to-day Operational Support including:
• Direct Manufacturing Support required for Critical Operations
• 24 x 7 Onsite/On Call as required.
• Trouble shooting Support to Manufacturing operations, cleaning systems, plant utilities and Building management system
• Automation System Administration
• Automation System Operating Systems (OS) security patching and HotFix assessments and rollout
• Daily manufacturing and engineering work center team meetings
• Preventative and corrective maintenance
• Automation System spare parts management

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Automation professional We seek has these qualifications:

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of Manufacturing Automation Engineering experience

Or

Bachelor’s degree and 5 years of Manufacturing Automation Engineering experience

Or

Associate degree and 10 years of Manufacturing Automation Engineering experience

Or

High school diploma / GED and 12 years of Manufacturing Automation Engineering experience

Preferred Qualifications:

• Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.
• Demonstrated hands-on experience in developing process control strategies in Clinical/Commercial Drug Substance Plant Operations.
• Familiarity with Upstream and Downstream unit operations.
• Direct knowledge of Automation design, experience in process control engineering and trouble shooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, and ultrafiltration/diafiltration, roller bottle processing, and integrating various OEM automation software.
• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times; reduced plant utilities usage) related to Drug Substance Plant Operations.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope, and cost estimate development, case development, detailed design, engineering and validation documentation and project execution are a plus.
• The ideal individual must be a self-directed standout colleague ready to mentor. engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
• Ability to perform independently, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
• 3+ years’ combined experience with the following:
• Emerson Delta-V DCS system
• Rockwell Automation SCADA and PLC Platform.
• ABB Robotics
• Mitsubishi Programmable Logic Controllers
• Electronic Batch Reporting Systems Design and implementation experience.
• Process Control Network design including network segregation.
• Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced trouble shooting activities in coordination with Amgen IS.
• System Integration using OPC, Profibus, Serial VIM, Ethernet and DeviceNet technologies.
• Compliance and regulatory requirements such as 21 CFR Part 11, S88, S95 and GAMP.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range