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

Amgen•New Albany, OH

3d•$88,281 - $119,439

About The Position

Support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at Amgen’s Ohio site. Apply engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle. Contribute to technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. The role supports qualification and validation planning and execution, process and equipment troubleshooting, cross-functional project delivery, supplier coordination, documentation review, and inspection readiness. It also contributes to operational excellence and improvements in throughput, reliability, process capability, and CQV methods. Approximately 20% travel is expected.

Requirements

Master’s degree; or bachelor’s degree and 2 years in a GMP-regulated environment; or associate’s degree and 6 years in a GMP-regulated environment; or high school diploma/GED and 8 years in a GMP-regulated environment.
Approximately 20% travel.
Excellent written and verbal communication skills and demonstrated ability to work in a team environment.
Demonstrated ability to contribute to cross-functional technical projects.
Ability to learn rapidly in a complex, fast-moving GMP environment.
Passion for delivering excellent work and developing others, with a positive attitude.

Nice To Haves

Understanding of combination product assembly technologies, automated and semi-automated equipment, and packaging operations.
Experience supporting CQV activities, including protocol writing, execution, and data analysis.
Experience working with manufacturing equipment suppliers.
Lean/Six Sigma exposure and an Operational Excellence mindset.

Responsibilities

Complete commissioning activities and author and implement IQ/OQ/PQ protocols, validation plans, and lifecycle documentation.
Maintain the validated state of equipment and processes through periodic reviews and documentation updates.
Participate in equipment and system design reviews, supporting requirements definition and alignment of CQV strategy.
Support and participate in FAT/SAT, equipment installation, and startup readiness.
Collect and analyze process and equipment data for validation, characterization, and sustained performance.
Support technical transfer of FDP and combination product processes into the Ohio site, ensuring CQV deliverables are met.
Perform data collection and process characterization for new equipment and process introductions.
Troubleshoot device assembly and packaging equipment using engineering fundamentals and cross-functional support.
Provide technical input to change control, deviations, CAPA, and risk assessments related to validation activities.
Support CQV project planning, schedule alignment, and execution for new or modified equipment and systems.
Partner with Manufacturing, Process Development, Engineering, and Quality to deliver project milestones on time.
Communicate with Ohio site teams and the broader Amgen network to maintain alignment on technical deliverables.
Support documentation reviews, supplier interactions, and internal readiness for inspections or audits.
Serve as a technical resource for automated and semi-automated device assembly and packaging equipment.
Support troubleshooting and lead investigations into technical issues affecting equipment performance or reliability.
Review vendor documentation, test protocols, and engineering drawings for compliance with CQV requirements.
Evaluate equipment and process performance trends and identify improvement opportunities.
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 improve efficiency and compliance.
Build collaborative relationships with site and network groups, including Process Development, Manufacturing, Quality Assurance, Engineering and Maintenance, global technical and validation networks, and external equipment suppliers.
Use collaborative networks to support equipment qualification, technical troubleshooting, validation standardization, and performance trending.