Senior Engineer Analytical – QC System Owner

Career Category

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.

Senior Engineer Analytical – QC System Owner

What you will do

Let’s do this. Let’s change the world. In this vital role you will 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. Responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.

• Recognized as System Owner & Business Administrator for QC 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, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
• Participation in technical project teams to function as a subject matter expert on instrument validation regulations and procedures.
• Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.
• Scheduling of repairs and maintenance to minimize level of down-time for lab equipment, and disruption to laboratory activities.
• Writing/contributing to equipment operating procedures and manuals.
• Designing and conducting training for QC staff, and other department staff as applicable.
• Owns and project manages change controls and adhere to 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.
• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
• Development of laboratory equipment specifications to use for procurement of new laboratory equipment and instruments.
• A key contributor to Data Integrity Assessments for Lab systems
• Capable of defending Amgen’s Lab systems validation and data integrity philosophy in an Audit situation
• Any other tasks/projects assigned as per manager’s request.
• Develop, coordinate, analyze, and present res