Validation Engineer CSV CQV Focus

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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).

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Key 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

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Qualifications

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