Validation Engineer - CQV - Katalyst CRO : Job Details

Join to apply for the Validation Engineer - CQV role at Katalyst CRO.

• Prepare technically accurate documents for system lifecycle deliverables, ensuring high quality and compliance with validation standards.
• Develop and implement strategies, approaches, and procedures related to process validation.
• Ensure documentation practices adhere to cGXP requirements and 21 CFR Part 11 compliance.
• Write and review SOPs, Work Instructions, Risk Assessments, and validation protocols for pharmaceutical manufacturing systems.
• Execute qualification and validation activities, including protocols, reports, and traceability matrices.
• Perform temperature/humidity mapping and airflow visualization qualifications as needed.
• Investigate deviations, out-of-spec results, and perform CAPAs and change controls.
• Collaborate effectively with cross-functional teams and manage multiple tasks efficiently.
• Communicate clearly through reports, emails, and presentations, and interpret engineering drawings and manuals.
• Utilize Microsoft Office and other relevant software, with preferred experience in Blue Mountain and Veeva Vault.

• BA/BS in Science or Engineering; advanced degree preferred.
• At least 4 years of experience in equipment qualification and technical writing within FDA-regulated industries.
• Experience in executing validation projects, developing procedures, and managing documentation in compliance with industry standards.

• Position: Associate, Contract
• Industry: Pharmaceutical Manufacturing
• Location: Warren, NJ (or nearby locations with posted salary ranges)