Validation Engineer (Pharmaceutical Manufacturing)

Location: 111 Fieldcrest Ave, Edison, New Jersey, United States; onsite role

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

Company

hirify.global operates global ecommerce businesses in beauty and sports nutrition. Bentley Laboratories is a beauty contract manufacturer producing skincare, haircare, hygiene, color cosmetics, OTC products, and related formulations in Edison, New Jersey.

What you will do

• Author and execute IQ, OQ, and PQ protocols for compounding, blending, and high-speed packaging equipment.
• Maintain the Validation Master Plan and re-validation schedules; review P&IDs, electrical schematics, and functional specifications to define testing criteria.
• Develop risk-based cleaning validation protocols, establish residue limits, determine worst-case active ingredients, and calculate ADE and MACO.
• Qualify USP purified water, compressed air, and HVAC systems supporting cleanroom environments.
• Oversee PPQ for new or modified OTC formulations and optimize blending times, temperatures, and fill weights.
• Partner with R&D and tech transfer teams to scale production from pilot batches to commercial manufacturing.

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 covering OTC drugs, pharmaceuticals, medical devices, or cosmetics.
• Deep understanding of FDA 21 CFR Parts 210/211 and ICH guidelines.
• Experience with surface swabbing and rinse-water sampling 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 experience authoring clear, audit-ready summaries and reports.

Nice to have

• Familiarity with Computer System Validation, GAMP 5, and 21 CFR Part 11 for automated manufacturing software, PLCs, and LIMS.
• Experience applying FMEA and other risk management tools to identify and mitigate process risks.
• CPIP or Lean Six Sigma Green Belt or Black Belt certification.

Culture & Benefits

• Collaborative environment focused on quality, accountability, innovation, teamwork, respect, continuous improvement, GMP, and safety.
• Employees are empowered to support operational excellence and deliver compliant products and services.
• THG is a Disability Confident Committed employer and supports reasonable adjustments during the recruitment process.
• THG is committed to diversity and inclusion and welcomes applications from all sections of the community.