Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
The 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.
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.
EducationBachelor'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
| Location | New Albany, OH |