Validation Engineer

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).

• 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 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