Sr Automation Engineer
About The Position
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. 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.
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
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
