Validation Engineer | Bentley Labs

THG • Edison, NJ

18h • Onsite

About The Position

Bentley Laboratories, a beauty contract manufacturer based in Edison, New Jersey, is hiring a Validation Engineer. The role supports validation activities for manufacturing equipment, processes, cleaning procedures, and plant utilities in a cGMP environment producing OTC drugs and beauty products. The engineer authors and executes qualification protocols, maintains the Validation Master Plan, and works with engineering documentation to establish testing criteria.

The position also covers risk-based cleaning validation, including setting residue limits and assessing worst-case ingredients, as well as qualifying purified water, compressed air, and HVAC systems. The engineer oversees process performance qualifications for new or modified OTC formulations and partners with R&D and technology transfer teams to scale production from pilot batches to commercial manufacturing.

Bentley Labs describes its workplace as collaborative, with an emphasis on quality, accountability, innovation, teamwork, respect, continuous improvement, GMP and safety standards, and operational excellence. The role is located at 111 Fieldcrest Ave, Edison, NJ 08837. Compensation is $95,000–$110,000 annually, based on experience, skills, and qualifications.

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 computer system validation of 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 engineering drawings, including P&IDs and 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, identify 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 that regulate cleanroom environments.
• Oversee Process Performance Qualifications (PPQ) for new or modified OTC drug formulations, including optimization of blending times, temperatures, and fill weights.
• Partner with R&D and technology transfer teams to scale production from pilot batches to commercial-scale manufacturing.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level