GMP Project Manager

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

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 Project Manager is recognized as a strong technical contributor within the Engineering Team supporting facilities, maintenance, project engineering, manufacturing, and validation/QA.  The Project Manager also has excellent communication skills, interpersonal skills, technical writing skills, creative problem-solving skills, and has a team-oriented attitude.  To succeed in this role, you should have extensive “hands on” experience in the manufacturing environment.

You will manage multiple projects concurrently, participate in cross functional teams, and manage all project aspects with technical expertise. As the Project Manager your duties will include, but are not limited to, scope development, funding approvals, concept and detailed engineering, contractor selection, project execution, commissioning and qualification, and turnover including As-Built drawings, PM plans, spare parts, asset records, C&Q documents, and all technical records.

Responsibilities:

• Manage all aspects of engineering projects
• Supports the Management of Change process and utilizes good documentation practices
• Ensures GMP compliance (e.g. work order processing, good documentation practices, compliance to change management process, deviation review, CAPA assignments, etc.)
• Responsible for installation and maintainability of GMP utilities, facilities, and equipment such as but not limited to HVAC, compressed gases, process water, clean steam, chilled water, cleanrooms, glovebox isolators, HEPA filtration, manufacturing equipment, and control systems, etc.
• Monitors the performance and results of the construction team including safety, quality, reliability, and availability of assets
• Performs effective problem solving and root cause analysis to resolve issues, develop options, and prevent reoccurrence

Minimum Qualifications:

• Bachelor’s Degree in an Engineering discipline, Chemical, Mechanical, etc.
• 10+ years engineering experience within a pharmaceutical, chemical, or production environment including 3+ years experience managing capital engineering projects in a GMP regulated environment

Preferred Qualifications:

• Hands on experience and strong project management skills in an industrial environment
• Strong technical engineering skills
• GMP manufacturing, engineering, or compliance experience
• Demonstrated ability to work within a cross-functional team
• Ability to coach, motivate, and occasionally managing a team of peers and contractors.
• Excellent interpersonal and team building skills
• Skilled on Microsoft Suite of Applications (Outlook, Word, Excel, Project, Power Point), and other project management tools
• Skilled in cGMP environment 
• Able to interpret mechanical, architectural, controls, and electrical specifications, drawing, loop diagrams, design specification, and validation requirements.
• Knowledge of National Electrical Code
• Knowledge of FDA, cGMP regulations 21 CFR Part 11, 210, and 211.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!