Validation Engineer 3

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:

• Lead and manage complex validation activities across the facility to ensure full compliance with cGMP, FDA, and EU regulations (including 21 CFR 210 & 211; 21 CFR Part 11; EU GMPs; ICH Q7, Q8, Q9, Q10).
• Oversee the planning, research, and execution of advanced validation protocols (IQ, OQ, PQ) for process, equipment, facility, utility, computer systems, and cleaning requirements.
• Drive project management efforts for large-scale validation projects, including project estimating, budgeting, scheduling, risk assessment, and overall coordination with cross-functional teams.
• Mentor and provide technical leadership to junior validation engineers, ensuring adherence to best practices in validation, documentation, and revalidation processes.
• Analyze complex validation data using statistical tools, synthesize results, and prepare detailed Summary Reports for senior management review.
• Evaluate impact and provide recommendations on change control requests for validated systems, ensuring all modifications maintain compliance and validation status.
• Lead the development and continual improvement of Standard Operating Procedures (SOPs) for new and existing equipment and processes.
• Represent the validation function during internal and external audits, providing expert insights and quick resolution to findings or deviations.
• Collaborate on cross-department projects related to new equipment/systems implementation and media fills, acting as the primary validation contact.
• Ensure ongoing training and competency in handling hazardous materials and waste according to mandatory safety standards.

Who You Are:Minimum Qualifications:

• Bachelor’s Degree in Biology, Chemistry, Chemical Engineering, Biomedical Engineering, or other Life Science or Engineering discpline.
• 5+ years of hands-on validation experience in a sterile/aseptic pharmaceutical environment.

Preferred Qualifications:

• Extensive experience with aseptic bulk process formulation, aseptic filling systems, and process control validation in pharmaceutical manufacturing.
• Strong expertise in the qualification of sterile facility equipment and computerized systems (including hands-on use of instruments like the Kaye Validator and Val Probe, and proficiency with PLC software such as A-B and Honeywell).
• Strong leadership and mentoring skills with the ability to guide teams through complex projects.
• Strong computer competencies including proficiency in spreadsheets, word processing, databases, and relevant quality/document management systems.
• Strong organizational, analytical, verbal, and written communication skills, with a track record of independent decision-making and effective collaboration in high-stress environments.

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!