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The Hut Group

Ecommerce platform powering beauty and wellness

Validation Engineer - Bentley Labs

Regulatory & Quality (Life Sciences)Updated on Nov 9
Full-timeEdison, NJ, USA$95k - $110k /yr

About the Job

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, including 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.
  • Technical writing skills and experience authoring clear, audit-ready summaries and reports.

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 draft testing criteria.
  • Develop cleaning validation protocols using a risk-based approach 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 drug formulations, ensuring blending times, temperatures, and fill weights are optimized.
  • Partner with R&D and tech transfer teams to scale up production from pilot batches to commercial-scale manufacturing.

Desired Qualifications

  • Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 for validating automated manufacturing software, PLCs, and laboratory information systems (LIMS).
  • Experience applying Risk Management tools, including FMEA, to identify and mitigate process risks.
  • Certified Pharmaceutical Industry Professional (CPIP) certification or Lean Six Sigma Green Belt or Black Belt certification.

About the Company

The Hut Group

Ecommerce platform powering beauty and wellness

THG is a global ecommerce platform that helps brands reach shoppers online, operating in beauty, health, wellness, and sports nutrition. It sells its own brand Myprotein and partners with more than 1,300 premium beauty brands, using its Ingenuity platform to connect product development, manufacturing in the UK and USA, and online sales across major markets. The end-to-end system gives brands a single place to manage listings, fulfillment, and customer experience on both owned and partner brands. THG’s goal is to grow digital commerce by expanding its own brands, supporting partner brands, and pursuing scalable, sustainable global growth.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Manchester, United Kingdom
Founded
2004

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