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Lead Computer Systems Validation Engineer - Cellipont Bioservices
Software Engineer
Lead the design and execution of risk‑based CSV strategies for new systems, upgrades, and lifecycle maintenance, ensuring compliance with GMP and regulatory standards while driving innovation in cell therapy manufacturing.
About the role
Key Responsibilities
- Develop and implement risk‑based CSV strategies for new system implementations, software upgrades, and configuration changes.
- Lead the creation and maintenance of validation documentation, including system assessments, test plans, and reports.
- Coordinate cross‑functional teams to ensure timely delivery of CSV deliverables and adherence to GMP and regulatory requirements.
- Conduct remediation activities and lifecycle maintenance to sustain validated status of critical manufacturing systems.
- Provide technical guidance and mentorship to junior CSV staff and stakeholders.
Requirements
- Extensive experience in Computer Systems Validation within a GMP environment.
- Strong knowledge of risk‑based validation principles and regulatory guidelines (e.g., FDA, EMA).
- Proficiency in documenting validation activities and managing change control processes.
- Excellent communication skills and ability to collaborate with cross‑functional teams.
- Bachelor’s degree in Life Sciences, Engineering, or related field; advanced certifications in CSV are a plus.