Position SummaryThe Sr. Cold room Automation Engineer (CW) will play a critical role leading the design, construction, commissioning,Startup, qualification, validation, training and operation of Amgen CO2 Cold Chain (Cold Rooms/Refrigerationsystems with ASRS).
This role partners closely with Site Facility & Engineering (F&E), Packaging operations, Warehouse, Quality, Technologies/DTI/IT and external cold room vendors to ensure Cold Room/Refrigeration systems and processes are designed, implemented, and operated in compliance with Amgen cold room specifications as well as GxP, safety, and quality requirements. The engineer will serve as a technical subject matter expert and contribute to the development of reliable, scalable, and compliant cold chain solutions.
Key Responsibilities- Lead the design of Cold Room/Refrigeration systems and processes used in Amgen Manufacturing, Packaging
and Warehouse operation - Ensure the cold room design meet engineering, safety, quality, and regulatory compliance specifications and
requirements - Lead commissioning, qualification, validation, startup and operation of new AOH ASRS cold room with CO2.
- Lead and support the development, testing, implementation, validation, and operation of critical automation
and software systems. - Support Commissioning, Qualification, and Validation (CQV) activities for the cold room systems.
- Lead cold room operational training and system adoption
- Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT
teams to maintain GxP compliance. - Serve as a recognized Engineering Subject Matter Expert (SME) for cold room systems, establishing
operational methodologies and best practices. - Ensure commissioning and qualification activities align with project requirements, milestones, and schedule
commitments. - Apply engineering principles and practices across cold room automation, controls and integrated systems Drive continuous improvement to simplify and optimize cold room design and operational processes.
- Demonstrate a strong understanding of OT/IT convergence, industrial networks, and system integration.
- Work closely with cold room vendors/consultants, ensuring contracts, technical specifications, and
deliverables meet Amgen requirements. - Effectively lead and influence teams, achieving both technical outcomes and strong collaboration.
QualificationsEducationBachelor's or Master's degree in Mechanical Engineering or related discipline
Experience & Requirements- 10+ years in Industrial Refrigeration and Cold room Design
- 5+ years in CO2 cold room design and operations
- Proficiency in Automated processes, technologies and systems deployment and adoption
- Strong project management and communication skills
- Strong knowledge of cGMP and validation processes.
- Experience working in an operational GxP-regulated environment with a strong understanding of
applicable regulations and standards - Direct experience working in regulated environments (GMP, OSHA, EPA)
- Willingness to travel (30%), as required; Fluent in English with effective communication skills
