Job Description

Sr. Validation Engineer

• Coordinate with cross-functional stakeholders (Engineering, Maintenance, QA, Production, System Owners) for system installations and modifications.
• Author and update SOPs related to Operations, Maintenance, and Computer System Validation.
• Develop and train on Admin SOPs covering access levels, parameter management, and administrative controls.
• Provide computer validation training programs ensuring compliance with regulatory standards.
• Train new team members and interns on validation project processes and documentation standards.
• Assign, guide, and review tasks for interns and new team members.
• Prepare and manage Engineering Turnover Packages (ETOPs) to ensure quality and consistency.
• Implement and maintain Change Management, CAPA, Risk Analysis (FMEA), and GAP Analysis procedures.
• Initiate, track, and close Change Control Requests (CCRs) with proper documentation and compliance.
• Lead and support Client, Internal, and Vendor Audits with thorough documentation and follow-ups.
• Support and actively participate in FDA audits by preparing validation documentation, addressing audit queries, and ensuring all protocols, reports, and change controls were compliant with 21 CFR Part 11 and cGMP standards.
• Author and manage change control documents, including FMEA, Impact Assessments, Test Scripts, CAPAs, and IQ/OQ/PQ protocols.
• Perform biostatistical analysis using tools like SAS and R.
• Conduct Engineering Studies for optimal recipe parameter development (tuning and production style runs) for manufacturing equipment.
• Author equipment decommissioning protocols; Decommission packing equipment and document asset retirement and closure through site procedures.

Requirements:

• BS in Biology, Biomedical Informatics or a related field with 5+ years of experience in pharmaceutical manufacturing facility validation or Master’s degree with 1 year experience.

Job Tags

Similar Jobs