Senior Engineer, Process Validation
Danaher · Remote +7 more
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Role summary
Aldevron, a Danaher operating company, seeks a Senior Engineer to lead process validation projects supporting commercialization of therapies. The role involves designing and executing validation strategies across drug substance and product stages, managing sterile fill-finish qualification programs, and applying risk-based approaches and statistical tools. The position reports to the Process Validation Manager and is fully remote.
What they're looking for
- Bachelor's or Master's degree in engineering
- 5+ years of process validation experience in biologics manufacturing
- Knowledge of global regulatory requirements and cGMP regulations
- Proficiency in technical writing, deviation investigations, and root cause analysis
- Experience with statistical analysis, risk assessment, and process improvement tools
- Familiarity with FDA guidance and EU GMP Annex 15 requirements
What you'll be doing
- Design and execute process validation across characterization, qualification, and commercial stages
- Lead sterile fill-finish and aseptic manufacturing process validation strategies and programs
- Apply risk-based approaches and statistical tools to evaluate process performance
- Serve as technical subject matter expert for external clients and internal teams during audits and inspections
- Mentor junior validation associates in cGMP regulations and Quality by Design principles
Privacy & handoff
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