Job Description

Job Summary

· Primary: CSV (Computer System Validation) Compliance

· Secondary: SDLC / CSA / Validation Governance / Quality Compliance

• Lead CSV compliance activities for capital and strategic projects.
• 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.
• Candidates will need to be legally authorised to live and work in the United States and be willing to commute to site approximately three days per week

Key Responsibilities

· Primary: CSV (Computer System Validation) Compliance

· Secondary: SDLC / CSA / Validation Governance / Quality Compliance

• Lead CSV compliance activities for capital and strategic projects.
• 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.
• Candidates will need to be legally authorised to live and work in the United States and be willing to commute to site approximately three days per week

Skill Requirements

Other Requirements