Validation Engineer | Bentley Labs
About The Position
Bentley Laboratories, a beauty contract manufacturer based in Edison, New Jersey, is seeking a Validation Engineer to support quality, compliance, and operational excellence in its manufacturing environment. The role focuses on equipment, cleaning, utility, and process validation for OTC products and related manufacturing systems. The Validation Engineer authors and executes IQ, OQ, and PQ protocols for compounding, blending, and high-speed packaging equipment; maintains the Validation Master Plan and re-validation schedules; and reviews engineering drawings and functional specifications to develop testing criteria. The role also develops risk-based cleaning validation protocols, establishes residue limits and worst-case actives, calculates ADE and MACO, and qualifies critical plant utilities including purified water, compressed air, and cleanroom HVAC. The role oversees PPQ for new or modified OTC formulations and works with R&D and technology transfer teams to scale production from pilot batches to commercial manufacturing. The successful candidate brings recent cGMP validation experience, strong regulatory knowledge, and excellent technical documentation skills.
Requirements
- Bachelor’s degree in chemical engineering, mechanical engineering, biomedical engineering, chemistry, or a related scientific discipline.
- 3 to 5+ years of recent validation experience strictly within a cGMP environment, such as OTC drugs, pharmaceuticals, medical devices, or cosmetics.
- Deep understanding of FDA 21 CFR Parts 210/211 and ICH guidelines.
- Proficiency in surface swabbing and rinse-water sampling techniques for cleaning verification.
- Experience operating validation data loggers, such as Kaye Validator or Ellab, for thermal qualification of autoclaves, tunnels, and stability chambers.
- Exceptional technical writing skills and a track record of authoring clear, audit-ready summaries and reports.
Nice To Haves
- Familiarity with GAMP 5 and 21 CFR Part 11 for validating automated manufacturing software, PLCs, and laboratory information systems (LIMS).
- Experience applying risk management tools such as FMEA to identify and mitigate process risks.
- Certified Pharmaceutical Industry Professional (CPIP) certification or Lean Six Sigma Green Belt or Black Belt.
Responsibilities
- Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for compounding, blending, and high-speed packaging equipment.
- Maintain the Validation Master Plan (VMP) and keep equipment and systems re-validation schedules current and compliant.
- Review P&IDs, electrical schematics, and functional specifications to develop testing criteria.
- Develop risk-based cleaning validation protocols to prevent cross-contamination between OTC product formulations.
- Establish residue limits, determine worst-case active ingredients, and calculate acceptable daily exposure (ADE) and maximum allowable carryover (MACO).
- Qualify critical plant utilities, including USP purified water systems, compressed air, and HVAC systems regulating cleanroom environments.
- Oversee Process Performance Qualifications (PPQ) for new or modified OTC formulations, optimizing blending times, temperatures, and fill weights.
- Partner with R&D and technology transfer teams to scale production from pilot batches to commercial-scale manufacturing.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
