Job Description-
• Lead CSV compliance activities for capital and strategic projects.
Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all).
• Develop, Review and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, such as CFR 21 Part 11.
• Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches.
• Participate in project meetings and CSV compliance reviews.
• Assist with project change controls, and CSV compliance-related risk assessments.
• Maintain project CSV compliance trackers, metrics, and reporting.
• Approval of SDLC documents as technical unit
• Minimum 5 years' experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab and Quality Systems within a regulated pharmaceutical or biotechnology environment.
Strong knowledge of:
• GAMP 5
• FDA 21 CFR Part 11
• EU GMP Annex 11
• Risk-based validation and CSA principles
• Software Development Lifecycle (SDLC)
• Change Management and Deviation processes
• Experience supporting capital projects and GMP computerized systems.
• Strong stakeholder management and communication skills.
• Ability to work independently across multiple projects and sites.
• Role based in West Point, PA (Must visit site 3 days a week)
• Candidates will need to be legally authorized to live and work in the United States and be willing to commute to site approximately three days per week.
