Indianapolis $100,000 - $120,000 Permanent
Serve as a technical subject matter expert (SME) for commercial and clinical manufacturing processes, ensuring reliable and compliant production performance.
Lead process troubleshooting, deviation investigations, and root cause analyses for upstream, downstream, or fill-finish operations.
Support technology transfer of new products and processes from development to manufacturing sites, including documentation and scale-up activities.
Author and review process descriptions, batch records, risk assessments, and change controls in alignment with cGMP requirements.
Collaborate with Quality, Validation, and Engineering teams to implement process improvements and corrective/preventive actions (CAPAs).
Monitor and trend process performance data (yields, deviations, cycle times, etc.) to identify improvement opportunities and ensure control state.
Provide technical support during regulatory inspections, audits, and process validation activities.
Partner with R&D and Process Development to optimize and characterize critical process parameters and ensure smooth handoffs to manufacturing.
Lead and mentor junior engineers or specialists within the MSAT team.
Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, or related life sciences discipline.
5–10 years of experience in pharmaceutical, biotech, or CDMO manufacturing support (drug substance, drug product, or aseptic operations).
Strong working knowledge of GMP manufacturing principles, process validation, and technology transfer.
Hands-on experience with bioreactors, filtration systems, chromatography skids, or fill-finish equipment, depending on area of focus.
Demonstrated ability to analyze complex process data, identify root causes, and drive improvements.
Experience supporting deviation investigations, CAPA, and change control systems.
Excellent technical writing, communication, and cross-functional collaboration skills.
Familiarity with process automation systems (DeltaV, Rockwell, or equivalent) and data trending tools preferred.
Continuous improvement, Six Sigma, or statistical analysis experience is a plus.
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