Position Title: Senior CSV Engineer
Role Overview: We're on the lookout for a seasoned Computer System Validation (CSV) Specialist to enhance our commissioning and qualification (C&Q) activities for a cell therapy manufacturing initiative. This pivotal role ensures our computer systems are compliant with regulatory standards, enabling smooth product manufacturing.
Key Duties:
- Formulate and implement CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment.
- Collaborate intimately with automation and validation teams to guarantee systems comply with project and regulatory standards.
- Oversee the document lifecycle, from creation and revision to storage, in accordance with project documentation systems.
- Engage in weekly project meetings to synchronize with system owners and management, ensuring alignment on project requirements and issue resolution.
- Perform risk assessments and compile compliance reports, managing deviations and ensuring all necessary documentation adheres to quality and regulatory standards.
- Supervise vendor interactions, including reviewing and tracking vendor deliverables and system qualifications.
Key Qualifications:
- Bachelor's degree in a pertinent field (e.g., Engineering, Computer Science, Life Sciences).
- At least 5 years of experience in Computer System Validation within a GMP-regulated environment, preferably in pharmaceuticals or biotechnology.
- Extensive knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards) and quality systems.
- Expertise in validating stand-alone computer systems, such as analytical instruments and lab equipment controlled by software.
- Superior organizational, communication, and documentation skills.
- Must be able to generate CSV deliverables independently.
