Senior Validation Engineer

 

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

This position is responsible for leading validation projects. Sr. Validation Engineer will be a senior member of the validation team developing, reviewing, executing and managing validation activities, and ensuring that the qualification/validation activities are consistent with user’s/manufacturer’s requirements and site quality standards. This role will be responsible for validation activities such as:

 

• Lead equipment and utility validation projects and manage project schedule.
• Act as technical lead for a cross-functional project and regularly interfaces with other groups to coordinate activities ensuring effective and clear communications.
• Work with equipment vendors to define requirements and understand functional specifications.
• Represent validation program during audits and inspections.

• Identifies and solves problems in experimental designs.

• Independently plans and designs experiments involving potentially conflicting design requirements.
• Investigates, adapts, or modifies experimental methods and technologies for project advancement.
• Independently analyzes complex data, interprets results, and suggests next experiment.
• Can act as technical lead for a cross-functional project and regularly interfaces with other groups to coordinate activities.
• Interfaces and collaborates with other groups to solve technical problems; typically guides peers in troubleshooting efforts.
• Maintains high level of expertise with relevant literature and guidance documents.
• Sources materials and resources internally/externally as needed for various projects.
• Provides additional support and cross-trains as business needs arise

Who You Are

Minimum Qualifications

• Master’s Degree in Engineering, Biology, or related science discipline with 6+ years of experience in Biologics, Pharma, Device or Biotech OR a Bachelor Degree in Engineering, Biology, or related science discipline with 12+ years of experience in Biologics, Pharma, Device or Biotech.
• 8+ years of experience in DQ, IQ, OQ, PQ for lab and/or manufacturing equipment, facilities and utilities.
• 8+ years of experience in temp. mapping of CTUs, autoclaves etc.
• 8+ years of experience in Asset management (BMRAM), temp. mapping and CSV projects per current requirements.
• 8+ years of experience of writing risk assessments per Quality Risk Management concepts and creating plans, protocols, reports and SOP’s for validation reports.

Preferred Qualifications

• Experience in Biologic manufacturing facility and site expansion.
• Experience with new facilities to support validation project from the site construction.
• Understanding of principles and concepts of Lean Six Sigma to continuously improve qualification program.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experience