Validation Engineer

Hamlyn Williams; Massachusetts; On-site; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Validation Engineer in Massachusetts. The role involves developing validation protocols, preparing documentation, and ensuring compliance with industry regulations. Ideal candidates will have a degree in Engineering or Life Sciences and relevant experience in validation.

Qualifications

• Bachelor's degree in Engineering, Life Sciences or related field required.
• 2–5 years of experience in validation.
• Strong understanding of GMP, GDP, and regulatory standards.

Responsibilities

• Develop and execute IQ/OQ/PQ protocols for equipment and processes.
• Prepare detailed validation documentation including plans and reports.
• Coordinate with cross-functional teams including QA and Engineering.

Skills

Validation

Technical writing

Regulatory compliance

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

TrackWise

ValGenesis

Job description

This range is provided by Hamlyn Williams. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$65.00/hr - $70.00/hr

• Validation experience required
• Start: ASAP
• Location: Onsite in MA
• Rate: Up to $65-$70 per hour, based on experience
• Duration: Through end of year, likely extension

Key Responsibilities:

• Develop and execute IQ/OQ/PQ protocols for equipment, utilities, software, and processes
• Prepare detailed validation documentation including plans, reports, deviations, and risk assessments
• Coordinate with cross-functional teams including QA, Engineering, Manufacturing, and R&D
• Perform gap analyses and support validation lifecycle management
• Ensure compliance with industry regulations (e.g., FDA, EU GMP, ISO 13485, 21 CFR Part 11)
• Support change control processes and revalidation as needed
• Participate in audits and regulatory inspections
• Continuously improve validation procedures and templates

Qualifications:

Required:

• Bachelor's degree in Engineering, Life Sciences, or a related field
• 2–5 years of experience in validation (equipment, process, software, or cleaning validation)
• Strong understanding of GMP, GDP, and regulatory standards
• Excellent technical writing and documentation skills
• Proficiency with validation tools and software (e.g., TrackWise, ValGenesis, or spreadsheets)

Preferred:

• Experience in pharmaceutical, biotech, medical device, or regulated industry
• Knowledge of risk-based validation and quality by design (QbD)
• Familiarity with CSV (Computer System Validation) or Annex 11

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing

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