Sr Automation Engineer

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 site 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 site 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 site 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 client requirements.

• Effectively lead and influence teams achieving both technical outcomes and strong collaboration.

Education

Bachelors or masters 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