Senior CSV Engineer Project Lead
Katalyst Healthcares & Life Sciences
Senior Csv Engineer Project Lead
The Senior Csv Engineer Project Lead is responsible for leading and executing Computer System Validation (Csv) activities for GxP-regulated systems, with a strong focus on Electronic Batch Record (Ebr) platforms. This role provides both technical and project leadership across the full validation lifecycle, ensuring compliance with FDA and global regulatory requirements while delivering projects on time and within defined scope. The position works closely with cross-functional teams including Quality, It, Manufacturing, Automation, and external vendors to support system implementations, upgrades, and continuous improvement initiatives.
Roles & Responsibilities:
- Lead and manage end-to-end Csv activities for GxP-regulated systems, with primary ownership of Ebr platforms.
- Plan, execute, and review validation deliverables including urs, frs, risk assessments, iq/oq/pq, and validation reports.
- Ensure compliance with FDA, Gamp 5, 21 CFR Part 11, and other global regulatory standards.
- Provide technical guidance and project leadership across multiple validation projects.
- Collaborate with Quality, It, Manufacturing, Automation, and vendors during system implementations and upgrades.
- Support change management, deviation management, and periodic reviews for validated systems.
- Ensure validation activities are completed on schedule and within project scope.
- Drive continuous improvement initiatives to enhance validation processes and system compliance.
- Act as a key point of contact for audits and regulatory inspections related to Csv.
Education & Experience:
- Strong experience in Computer System Validation (Csv) within GxP-regulated environments.
- Hands-on experience with Electronic Batch Record (Ebr) systems.
- In-depth knowledge of FDA regulations, Gamp 5, and 21 CFR Part 11 compliance.
- Proven experience leading validation projects and cross-functional teams.
- Excellent documentation, communication, and stakeholder management skills.
- Ability to work effectively with internal teams and external vendors.
- Experience in pharmaceutical, biotech, or life sciences industries.
- Prior experience handling regulatory audits and inspections.
- Project management experience or certification is an advantage.
Vacancy posted 2 days ago
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