Validation Engineer - Katalyst CRO : Job Details

We are seeking a skilled Validation Engineer to join our team. The ideal candidate will have experience in validation activities for computerized systems, ensuring compliance with 21 CFR Part 11 and knowledge of GAMP guidelines.

• Develop and review functional requirement specifications and risk assessments.
• Execute validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Prepare validation documents such as validation plans, change requests, and user requirements specifications.
• Ensure traceability matrix, project release notes, and system certification summaries are maintained.
• Prepare SOPs and work instructions for equipment and software-based systems.

• 6 to 8 years of experience as a Non-Product Software Validation Engineer, preferably with a manufacturing background in medical devices or diagnostics.
• Experience validating non-product software for manufacturing equipment per FDA and ISO standards.
• Proficiency in preparing and reviewing validation and testing documents.

• Seniority level: Mid-Senior level
• Employment type: Contract
• Industry: Pharmaceutical Manufacturing