Senior Engineer Analytical – QC System Owner

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 results for operational issues and engineering projects
• Provide technical support to commercial and clinical manufacturing as needed.
• Working closely with QC to implement operational improvements
• Communicating with QC staff, highlighting issues and proposing solutions.
• Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.
• Provide technical support and issue resolution with 24x7 on-call support of QC systems on a rotational based frequency.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.
• Ensure systems are installed and operating safely and align with pertinent environmental health/safety practice, rules and regulations.
• Ensure vital commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineer professional we seek is a subject matter expert with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience OR
• Associate’s degree and 8 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer OR
• Bachelor’s degree and 4 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer OR
• Master’s degree and 2 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience OR
• Doctorate degree

Preferred Qualifications:

• Bachelor’s degree in engineering or related technical field
• Laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.
• Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
• Demonstrated success in managing an equipment qualification or maintenance program.
• Ability to provide On-Call support coverage nights and weekends, on a rotating basis.
• Position requires strong written and verbal skills and the ability to work with minimum direction.
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
• Ability to function within multi-functional teams and adopt a team-based environment.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now!!

for a career that defies imagination

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

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.