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

Amgen•New Albany, OH

4d•$88,281 - $119,439

About The Position

The Engineer - Process Development supports commissioning, qualification, and validation (CQV) of GMP equipment and processes for Final Drug Product (FDP) operations at Amgen’s Ohio (AOH) site. The role applies engineering and scientific principles to ensure new and existing systems meet company and regulatory requirements throughout the validation lifecycle. As a contributor to the site’s growth, this position supports technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. The work helps ensure production systems are reliable, compliant, and efficient. The role also collaborates with site and network teams and external equipment suppliers. Travel is approximately 20%.

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.

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.
Excellent written and verbal communication skills and demonstrated ability to work in a team environment.
Demonstrated ability to contribute to cross-functional technical projects.
Experience working with manufacturing equipment suppliers.
Ability to learn rapidly in a complex, fast-moving GMP environment.
Operational Excellence mindset; Lean/Six Sigma exposure preferred.
Passion for delivering excellent work and developing others, with a positive attitude.

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, including requirements definition and alignment of CQV strategies.
Support and participate in factory and site acceptance testing (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 AOH and ensure CQV deliverables are met.
Troubleshoot device assembly and packaging equipment using engineering fundamentals and cross-functional support.
Provide technical feedback for 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.
Collaborate with Manufacturing, Process Development, Engineering, Quality, site teams, and the broader Amgen network to deliver project and 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 CQV compliance.
Evaluate equipment and process performance trends and identify improvement opportunities.
Support improvements in throughput, reliability, and process capability across packaging and assembly operations.
Participate in Lean, Six Sigma, and Operational Excellence initiatives.
Support data-driven decisions through process monitoring, trend analysis, and equipment performance assessments.
Recommend improvements to CQV procedures, templates, and standard methodologies.
Build collaborative relationships with Site Process Development, Manufacturing and Quality Assurance, Engineering and Maintenance, Global Technical and Validation Networks, and external equipment suppliers.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Comprehensive employee benefits package.
Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.