Validation Engineer

Karwell Technologies • Waltham, Massachusetts, United States

📍 Location

Waltham, Massachusetts

⏰ Job Type

Full-time

📅 Posted

May 14, 2026

About the Role

                  Job Description: 

  We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment. 

  This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV). 

   Roles & Responsibilities: 

  Perform validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment 

  Ensure compliance with GMP and 21 CFR Part 11 standards 

  Develop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization procedures 

  Conduct equipment qualification activities (IQ/OQ/PQ) and ongoing perform...

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