Validation Engineer | Bentley Labs

Thg Plc; Edison (NJ); Presencial; USD 95.000 - 110.000; Jornada completa

Descripción de la vacante

THG, Bentley Labs is seeking a Validation Engineer in Edison, NJ. You will author IQ/OQ/PQ protocols for OTC drug formulations and oversee validation programs within a cGMP environment.

Requirements include a Bachelor’s in a scientific field and 3–5+ years of validation experience, with knowledge of FDA 21 CFR Parts 210/211 and robust technical writing for audit-ready reports. Competitive salary and benefits.

Formación

• 3–5+ years of validation in a cGMP environment.
• Deep understanding of FDA 21 CFR Parts 210/211 and ICH guidelines.
• Experience with cleaning verification sampling and swabbing.
• Strong technical writing for audit-ready reports.

Responsabilidades

• Author IQ/OQ/PQ protocols for OTC drug formulations.
• Maintain VMP and re-validation schedules.
• Review P&IDs and specifications to draft testing criteria.
• Scale up processes from pilot to manufacturing.

Conocimientos

Validation experience

cGMP

FDA 21 CFR 210/211

Technical writing

Educación

Bachelor’s degree in science/engineering

Herramientas

Kaye Validator

Ellab

Descripción del empleo

We are THG, a global ecommerce group on a mission to be the global online leader in beauty and sports nutrition.

Our portfolio of leading retailers and brands such as LOOKFANTASTIC, Myprotein, ESPA, Perricone MD, and Cult Beauty form our two core businesses: THG Beauty and THG Nutrition.

From Manchester to New York, we’re powered by a team of over 2500 people who work together, lead by example, and think BIG.

With us, you’ll go further, faster. What are you waiting for?

Location: 111 Fieldcrest Ave, Edison, NJ, 08837

Life at THG Beauty

We know that beauty isn’t one‑size‑fits‑all. Our portfolio of leading retailers and iconic beauty brands caters to everyone, everywhere, empowering customers all over the world to look and feel fantastic.

By combining our portfolio of owned brands with a marketplace for over 1,300 third‑party beauty brands through online retail sites LOOKFANTASTIC, Cult Beauty, and Dermstore, THG Beauty’s ambition is to be the global digital partner of choice across the beauty industry, supporting the channel shift to online.

THG Beauty’s breadth of relationships is unique to the beauty market; it engages with brands as a retailer, a brand owner, and a product developer and manufacturer, making it the industry’s digital strategic leader.

About Bentley Labs

Bentley Laboratories is a premier beauty contract manufacturer based in Edison, NJ. For over twenty years, Bentley has been a trusted supplier for the world’s top global beauty brands, creating and producing award‑winning innovations across the skincare, bodycare, haircare, hygiene and color cosmetics categories. Bentley’s core manufacturing capabilities include OTC’S; skincare emulsions; surfactant systems for haircare, bath & body products; hot fill processing for solid stick deodorants, lip balms, and other wax systems; and powders for dry shampoos and loose powder face applications. Known for its innovation capabilities, quality, and manufacturing excellence, Bentley maintains the highest standards in GMP compliance, safety, and operational efficiency.

Our Culture & What It Means to Work at Bentley Labs

At Bentley Labs, we value quality, accountability, innovation, teamwork, and respect. We offer a collaborative environment where employees are empowered to drive continuous improvement, uphold GMP and safety standards, and contribute to operational excellence while delivering exceptional products and service.

As a Validation Engineer, you’ll:

Protocol Development & Execution

• 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) to ensure all re‑validation schedules for equipment and systems remain current and compliant.
• Review engineering drawings (P&IDs, electrical schematics) and functional specifications to draft robust testing criteria.

Cleaning & Utility Validation

• Develop cleaning validation protocols using a risk‑based approach to prevent cross‑contamination between different OTC product formulations.
• Establish residue limits and determine worst‑case active ingredients, calculating 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.

Process Validation & Technology Transfer

• 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.

What skills and experience do I need for this role?

Education & Experience

• 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 (OTC drugs, pharmaceuticals, medical devices, or cosmetics).
• Regulations: Deep understanding of FDA 21 CFR Parts 210/211 and ICH guidelines.
• Sampling: Proficient in surface swabbing and rinse‑water sampling techniques for cleaning verification.
• Instrumentation: Experience operating validation data loggers (e.g., Kaye Validator, Ellab) for thermal qualification (autoclaves, tunnels, stability chambers).
• Documentation: Exceptional technical writing skills with a track record of authoring clear, audit‑ready summaries and reports.

Preferred Skills & Certifications

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

Compensation

• $95,000–$110,000 annually, based on experience, skills, and qualifications.

THG is proud to be a Disability Confident Committed employer. If you are invited to interview, please let us know if there are any reasonable adjustments we can make to the recruitment process that will enable you to perform to the best of your ability.

THG is committed to creating a diverse & inclusive environment and hence welcomes applications from all sections of the community.

Because of the high volumes of applications our opportunities attract, it sometimes takes us time to review and consider them all. We endeavour to respond to every application we receive within 14 days. If you haven't heard from us within that time frame or should you have any specific questions about this or other applications for positions at THG please contact one of our Talent team to discuss further.

We're a business who thrive on collaborative working. Are you happy working from our Bentley site? Address is 111 Fieldcrest Ave, Edison, NJ, 08837.