A Pharmaceutical Manufacturing Process Engineer designs and maintains manufacturing equipment, facilities and processes for a pharmaceutical company. Maintains process controls for the specific sterile processing requirements of pharmaceutical manufacturing.
Your Responsbilities Lead the design of Cold Room/Refrigeration systems and processes used in Customer's 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 the customer's requirements. Effectively lead and influence teams, achieving both technical outcomes and strong collaboration. Your Profile Bachelor's or Master's degree in Mechanical Engineering or related discipline 10+ years in Industrial Refrigeration and Cold room Design 5+ years 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 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
