MilliporeSigma · 2 hours ago
Validation Engineer 2
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$67K/yr - $101K/yr
2+ years expMilliporeSigma is a global leader in science and technology, dedicated to enriching lives with innovative solutions in Healthcare, Life Science, and Electronics. The Validation Engineer 2 is responsible for establishing and maintaining validated cleaning processes for equipment and ensuring compliance with regulatory standards.
BiotechnologyMedicalMedical Device
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)
Qualification
Required
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
Preferred
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
Benefits
Health insurance
Paid time off (PTO)
Retirement contributions
Other perquisites
Company
MilliporeSigma
Together with our colleagues, customers and stakeholders, we impact life and health with science.
10001+ employees
H1B Sponsorship
MilliporeSigma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (34)
2023 (33)
2022 (58)
2021 (29)
2020 (31)
Funding
Current Stage
Late StageLeadership Team
David Nogales
Head of Technology Strategy
Recent News
2025-09-23
2025-06-20
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