Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The GMP Facilities Engineer is recognized as a strong technical contributor within the Operations Team supporting the clean utilities required for cGMP API manufacturing. This position will support the Sr. Production Engineer for all clean utilities at the site, including purified water, WFI, Clean Steam, Clean Air, CIP/SIP systems, and process gases, and other supporting equipment and infrastructure. This role will be onsite at our Cherokee / St. Louis, MO facility.

• Coordinate activities with other departments including Manufacturing, Maintenance, Engineering, Quality Assurance, Validation, Quality Control, Project Management and Process Development
• Work with customer personnel, auditors, and regulatory authorities, as needed, to communicate system design, qualification, and status of clean utilities
• Support all activities associated with site's clean utilities, including but not limited to, operation, qualification, preventative maintenance, change control, shut-down activities, risk assessments, leading investigations, troubleshooting, root cause analysis and CAPA implementation
• Ensure planned and unplanned work is prioritized and managed closely to minimize equipment downtime and disruptions to Operations' schedule
• Maintain quality systems and cGMP compliance
• Assist with the execution of manufacturing processes by working with the Process Engineer
• Provide training on clean utilities
• Assists in factory and site acceptance testing for new equipment
• Supports equipment commissioning, qualification and validation activities related to GMP manufacturing
• Write, review and/or assist in the development of Manufacturing, Facility or Equipment Operating Procedures
• Generate and/or review user requirement specifications for clean utilities and processing equipment
• Identify, recommend, and implement replacement-in-kind, new or improved equipment and/or systems in support of existing clean utilities as well as new or existing manufacturing processes
• Research equipment providers and make recommendations and selections based on project requirements and business needs
• Drive continuous improvement to support customer and regulatory expectations

Physical Attributes:

• Lift up to 35 lbs. and pushing heavy vessels/ equipment
• Under 5% of the role may need to travel to another company site

Who You Are:

Minimum Qualifications:

• Bachelors in a Mechanical Engineering, Electrical, or other Engineering field

• 3+ years of industrial plant engineering experience in a manufacturing setting

Preferred Qualifications:

• Engineering background with knowledge of WFI, clean utilities, and general pharmaceutical plant infrastructure
• Experience with FDA, EMA, and other regulatory standards and requirements for clean utility
• Ability to understand regulatory requirements such as ICH Q7, 21CFR Part 210 and 211, 21CFR Part 600, and EMA guidelines as they relate to clean utilities and pharmaceutical manufacturing
• Ability to read and interpret P&IDs, equipment manuals and electrical/mechanical drawings
• Able to work with other teams to ensure the vital details related to the systems are fully coordinated

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html