Engineer

About the Role

Support the commissioning, qualification, and validation (CQV) of GMP equipment and processes for Final Drug Product (FDP) operations. Apply engineering and scientific principles to ensure 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.

Key Responsibilities

• 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, 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 multi-functional support.
• Provide technical feedback into change control, deviations, CAPA, and risk assessments related 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.
• Maintain effective communication with site teams and the broader Amgen network.
• 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 troubleshooting and lead investigations for technical issues impacting equipment performance or reliability.
• Review vendor documentation, test protocols, and engineering drawings for 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.
• Support data-driven decision-making through process monitoring, trend analysis, and equipment performance assessments.
• Recommend enhancements to CQV procedures, templates, and standard methodologies.
• 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 troubleshooting, validation standardization, and performance trending.

Requirements & Tech Stack

• Commissioning, Qualification, and Validation (CQV)
• GMP
• IQ/OQ/PQ protocols
• FAT/SAT
• change control, deviations, CAPA, risk assessments
• Lean, Six Sigma, Operational Excellence
• Automated and semi-automated device assembly and packaging equipment
• Combination product assembly technologies

Qualifications

• Basic Qualifications:
• 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
• Preferred Qualifications:
• 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.
• 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 to deliver an excellent work product and develop others with a positive attitude.

Travel: Approximately 20%