Validation Engineer

Katalyst CRO; Waltham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a detail-oriented Validation Engineer in Waltham, Massachusetts, to support validation and calibration for pharmaceutical manufacturing and sterile processing equipment. The ideal candidate has 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). This role involves performing validation activities, developing validation plans, and collaborating across teams to resolve discrepancies.

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.

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.

Skills

Regulatory compliance

Equipment qualification

Computerized System Validation (CSV)

GMP knowledge

Problem-solving skills

Communication

Cross-functional collaboration

Job description

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).

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