What are the responsibilities and job description for the Senior CSV Validation Engineer position at EPM Scientific?
Position Title: Senior CSV Validation Engineer
The Role Overview:
We are seeking a seasoned computer system validation professional to enhance our commissioning and qualification activities for cell therapy manufacturing initiatives. This critical role ensures our computer systems comply with regulatory standards, enabling smooth product manufacturing.
Key Responsibilities:
- Develop and implement computer system validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for manufacturing equipment.
- Collaborate closely with automation and validation teams to ensure systems meet project and regulatory requirements.
- Oversee the document lifecycle, from creation and revision to storage, in accordance with project documentation systems.
- Participate 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 relevant 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 standalone computer systems, such as analytical instruments and lab equipment controlled by software.
- Superior organizational, communication, and documentation skills.
- Able to generate CSV deliverables independently.
