Sr Automation Engineer

Sr. Cold Room Automation Engineer (CW)

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Position Summary

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/Refrigeration systems 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 meets 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.

Qualifications

Education Bachelor'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