Validation Engineer 2

The businesses of Merck KGaA, Darmstadt, Germany•Indianapolis, IN

About The Position

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. Your Role: In this role you are responsible for establishing, justifying, executing, and maintaining validated cleaning processes for equipment and processes supporting existing and new clients. The position ensures that cleaning validation activities comply with applicable cGMP, FDA, and EU regulations (including 21 CFR 210 & 211, 21 CFR Part 11, EU GMPs, ICH Q7, Q8, Q9, Q10), with specific focus on control of cleaning agents and minimization of cross-batch contamination risk.

Requirements

PhD in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 2+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.
OR
Master’s Degree in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 3+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.
OR
Bachelor’s Degree in Biology, Chemistry, Chemical Engineering, Physical Engineering or other Life Science or Engineering discipline and 5+ years of validation experience in a regulated pharmaceutical or biopharmaceutical environment.
1+ years of experience in an aseptic pharmaceutical environment with exposure to aseptic bulk formulation, aseptic filling, and packaging processes.

Nice To Haves

Prior experience in the qualification and validation of sterile facility equipment, such as sterilization technologies (Steam, Dry Heat, VHP, etc.), temperature-mapped chambers, aseptic equipment (washers, tunnels, cappers, RABS, isolators, etc.), pharmaceutical-grade utilities, process validation, and cleaning validation.
Experience in validation activities and the use of validation test equipment (e.g., Kaye Validator, Val Probe, PLC-based systems, temperature/pressure standards).
Strong verbal and written communication skills.
Self-motivated, highly organized, and conscientious, capable of working independently and in cross-functional teams in technically and mentally demanding situations.

Responsibilities

Establish, justify, and validate cleaning processes for new/modified equipment and clients, ensuring full compliance with FDA and internal regulatory standards.
Author and execute IQ/OQ/PQ and CV-specific protocols, managing 3–5 annual requalification for processes, equipment, and utilities.
Serve as the site SME for cleaning-related deviations, CAPAs, and change controls, leading investigations and cleanability studies.
Author, revise, and deliver training on cleaning SOPs to Manufacturing operators to ensure qualification and documentation compliance.
Develop cleaning validation strategies, including worst-case assessments and residue limits, to control cross-batch contamination risks.
Apply statistical tools for trend analysis and continued process verification to monitor and maintain cleaning performance.
Perform technical peer reviews of protocols, reports, and risk assessments while supporting Annual Product Quality Reviews (APQRs).
Provide cleanability requirements for new system designs and demonstrate proficiency in site electronic quality management systems (eQMS).