Title: Sr. Cold Room Automation Engineer
Onsite: New Albany OH
We are seeking a senior-level Automation Engineer to play a pivotal role in leading the design, construction, commissioning, startup, qualification, validation, training, and operation of CO2 cold chain systems within a GMP-regulated environment. This role will support critical cold room and refrigeration technologies, including ASRS-enabled cold storage systems, ensuring they are designed, implemented, and operated in compliance with Amgen cold room specifications as well as GxP, safety, quality, and regulatory requirements.
This individual will serve as a technical subject matter expert and work closely with Site Facility & Engineering (F&E), Packaging Operations, Warehouse, Quality, Manufacturing, Computer System Validation (CSV), IT/OT, and external cold room vendors to deliver reliable, scalable, and compliant cold chain solutions.
Key Responsibilities
Lead the design of cold room and refrigeration systems and processes used across manufacturing, packaging, and warehouse operations.
Ensure 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 systems utilizing CO2 refrigeration infrastructure.
Lead and support the development, testing, implementation, validation, and operation of critical automation and software systems supporting cold room functionality.
Support Commissioning, Qualification, and Validation (CQV) activities for cold room systems and ensure deliverables align with project requirements, milestones, and schedule commitments.
Lead cold room operational training, user readiness, and system adoption to support efficient startup and sustained operations.
Partner closely with Quality Assurance, CSV, Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance and support seamless system integration.
Serve as a recognized engineering subject matter expert for cold room systems, helping establish operational methodologies and best practices.
Apply strong engineering principles and practices across cold room automation, controls, and integrated systems.
Drive continuous improvement efforts to simplify and optimize cold room design and operational processes.
Demonstrate a strong understanding of OT/IT convergence, industrial networks, and system integration in support of automated cold chain operations.
Work closely with cold room vendors and consultants to ensure contracts, technical specifications, and deliverables meet project and site requirements.
Effectively lead and influence cross-functional teams to achieve both technical outcomes and strong collaboration.
Required Qualifications
Bachelor's or Master's degree in Mechanical Engineering or a related discipline.
10+ years of experience in industrial refrigeration and cold room design.
5+ years of experience in CO2 cold room design and operation.
Proficiency in automated processes, technologies, and systems deployment and adoption.
Strong project management and communication skills.
Strong knowledge of cGMP requirements 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 such as GMP, OSHA, and EPA.
Willingness to travel up to 30% as required, with strong English communication skills.
Thanks Regards,
JAYADEV
Sourcing Specialist
Phone (732)-997-6982 Ext: 308
Email jayadev.g@intellectt.com