Process Analytical Engineer

About this role

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Process   Analytical   Engineer    

What you   will do  

In this vital role, you will join the Facilities & Engineering (F&E) group and   be responsible for   planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina (ANC). This role includes hands-on troubleshooting and root cause analysis for analytical and laboratory systems, coordination of vendor support and repairs, execution and tracking of calibration, maintenance, and requalification activities through the Computerized Maintenance Management System (CMMS) Maximo, and direct support for manufacturing operations to improve equipment uptime and reliability. You will also author, own, and approve Validation Life Cycle documents for computer-related systems, including responsibility for Data Integrity testing and business administration of laboratory computer-related systems.  

• Support commissioning, qualification, validation, and system lifecycle documentation to   maintain   compliance and operational readiness.  

• Partner closely with manufacturing teams to resolve issues, improve system reliability, and minimize operational downtime.  

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Key responsibilities:  

• System ownership, reliability, and operations  

• Work with the capital project team to ensure systems are installed and   operate   safely,   comply with   pertinent environmental health and safety practices, rules, and regulations, and meet Amgen global engineering and design requirements.  

• Serve as   System   Owner and Business Administrator for   analytical   equipment.  

• Lead or work with teams in design, development and  selection  of new systems, instruments, calibration  capabilities  and consumable components.   

• Development of laboratory equipment specifications to use for procurement of new laboratory equipment and instruments.     

• Maintaining a current working knowledge  regarding  regulatory requirements for equipment qualification and calibration.    

• Support in generation and resolution of protocol discrepancies as  required .    

• Alerting Quality Control Management if equipment  fails to  meet calibration or qualification requirements and conducting impact assessments/investigations as  required .     

• Lead the development of calibration/maintenance programs, ensure the availability of spare parts, schedule repairs and maintenance, and coordinate maintenance execution to keep systems in proper working order and minimize disruption to laboratory activities.  

• Participation in technical project teams to function as a subject matter expert on instrument validation regulations and procedures.     

• Evaluate  the capabilities  of current and potential suppliers, and assess  new technologies  that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.   

• Writing/contributing to equipment operating procedures and manuals.    

• Designing and conducting training for   manufacturing   staff, and other department staff as applicable.    

• Own and project manage change controls while meeting applicable change control metrics.  

• Preparing and presenting periodic management updates on activities to senior management.    

• Conduct periodic reviews of instrument validation as part of validation life cycle.    

• Validation, compliance, and quality systems  

• A key contributor to Data Integrity Assessments for Lab systems    

• Support Amgen’s laboratory systems validation and Data Integrity philosophy during audit interactions.  

• Support   additional   tasks and   projects as   assigned by management.  

• Cross-functional support, projects, and continuous improvement  

• Develop, coordinate, analyze, and present results for operational issues and engineering projects   

• Provide technical support  for  commercial and clinical manufacturing as needed.   

• Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.   

• Identify , support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.   

• Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and support interactions with regulatory   inspectors   as necessary.  

• Apply basic en

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