Validation Engineer

Katalyst Healthcares and Life Sciences

Waltham, MA

Job Summary:

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 performance monitoring
Perform instrument calibration for equipment such as dual display light meters, open air shakers, and various scales
Support validation of sterilization and cleaning systems, including CIP Skids, isolators, parts washers, and autoclaves
Execute validation projects, ensuring timelines, budgets, and KPIs are met
Collaborate with manufacturing, quality, and engineering teams to troubleshoot issues and resolve validation discrepancies
Apply a risk-based approach to validation to ensure compliance and operational efficiency
Coordinate resources and activities for complex validation and CSV initiatives

Experience:

Experience in validation, calibration, or CQV within a pharmaceutical or regulated environment
Strong knowledge of GMP and 21 CFR Part 11 compliance
Proven experience with Computerized System Validation (CSV)
Hands-on experience with IQ/OQ/PQ and validation lifecycle documentation
Strong problem-solving, communication, and cross-functional collaboration skills

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Vacancy posted 2 days ago

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