Engineer - Process Development (Commissioning, Qualification, and Validation)

Career Category

Process Development

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.

Engineer - Process Development (Commissioning, Qualification, and Validation)

What you will do

Let’s do this. Let’s change the world. In this role, you will support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at the Amgen Ohio (AOH) site. You will apply strong engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle.

As a key contributor to AOH’s growth, you will play an essential role in technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. Your work will help ensure reliable, compliant, and efficient production systems that support Amgen’s mission of serving patients.

Key responsibilities of this role include:

Commissioning, Qualification & Validation (CQV)

• Complete commissioning activities and author/implement IQ/OQ/PQ protocols, validation plans, and lifecycle documentation.
• Maintain validated state of equipment and processes through periodic review and documentation updates.
• Participate in equipment and system design review, supporting requirements definition and CQV strategy alignment.
• Support and participate in FAT/SAT, equipment installation, and startup readiness.
• Collect and analyze process and equipment data to support validation, characterization, and sustained performance.

Technical Transfer & Process Support

• Support technical transfer of FDP and combination product processes into AOH, ensuring CQV deliverables are met.
• Perform data collection and process characterization to support new equipment and process introductions.
• Trouble shoot device assembly and packaging equipment through engineering fundamentals and multi-functional support.
• Provide technical feedback into change control, deviations, CAPA, and risk assessments (as applicable to validation activities).

Project Management & Multi-Functional Collaboration

• Support CQV project planning, schedule alignment, and execution for new or modified equipment and systems.
• Partner with Manufacturing, Process Development, Engineering, and Quality to ensure project deliverables are met on time.
• Maintain effective communication with AOH site teams and the broader Amgen network to ensure alignment on technical deliverables.
• Support documentation reviews, supplier interactions, and internal readiness for inspections or audits.

Technical Expertise & Equipment Support

• Serve as a technical resource for automated and semi-automated device assembly and packaging equipment.
• Support trouble shooting and lead investigations for technical issues impacting equipment performance or reliability.
• Review vendor documentation, test protocols, and engineering drawings to ensure compliance with CQV requirements.
• Evaluate equipment and process performance trends to identify improvement opportunities.

Operational Excellence & Continuous Improvement

• Identify and support improvements in throughput, reliability, and process capability across packaging and assembly operations.
• Participate in Lean, Six Sigma, and Operational Excellence initiatives to strengthen equipment performance and CQV processes.
• Support data-driven decision-making through process monitoring, trend analysis, and equipment performance assessments.
• Recommend enhancements to CQV procedures, templates, and standard methodologies to increase efficiency and compliance.

Partner Relationships & Collaboration Network

• Build collaborative relationships with key site and network groups, including:
• Site Process Development
• Manufacturing & Quality Assurance
• Engineering & Maintenance
• Global Technical & Validation Networks
• External Equipment Suppliers
• Leverage this network to support equipment qualification, technical trouble shooting, validation standardization, and performance trending.

Travel: Approximately 20%

What we expect of you

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