Technical Source is seeking a mid-level Equipment Validation Engineer to support commissioning and qualification activities for a GMP-regulated biopharmaceutical manufacturing facility in the Boston area. This role is hands-on and execution-focused, supporting equipment from installation through qualification to ensure compliance and startup readiness.

Key Responsibilities

• Execute commissioning and qualification (C&Q) activities for GMP equipment
• Author, review, and redline validation documentation (URS, FRS, DDS)
• Develop and execute IQ/OQ protocols and summary reports
• Support commissioning documentation and system turnover
• Partner with Engineering, QA, and vendors to resolve issues during execution
• Support change control processes and validation updates
• Ensure all documentation aligns with cGMP and GDP standards
• Maintain validation lifecycle documentation per client and project requirements

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in equipment qualification within GMP environments
• Hands-on experience executing IQ/OQ protocols
• Strong understanding of:
  • cGMP regulations
  • Good Documentation Practices (GDP)
  • FDA validation requirements
• Experience with change control systems
• Familiarity with 21 CFR Part 210, 211, and Part 11
• Ability to work onsite in a cross-functional project environment

Preferred Experience

• Experience with parts washers and/or cleaning validation
• Exposure to a variety of biopharma manufacturing equipment
• Experience supporting commissioning (not just documentation)
• Background in fast-paced or startup/expansion environments