We are seeking an experienced Computer System Validation (CSV) Lead to provide validation and compliance oversight for computerized manufacturing and laboratory systems within a GMP-regulated pharmaceutical environment.
The successful candidate will support capital and strategic projects, lead validation lifecycle activities, and advise cross-functional teams on GxP, Computer Software Assurance, qualification, risk management, and change control requirements.
Key Responsibilities
- Lead CSV and compliance activities for computerized manufacturing and laboratory systems.
- Provide validation oversight for capital and strategic projects.
- Develop, review, and approve validation lifecycle documentation in accordance with GxP requirements, internal SOPs, and regulatory expectations.
- Guide project teams on CSV, CSA, SDLC, qualification, risk-based validation, and change control processes.
- Support the preparation and execution of IQ, OQ, and PQ documentation.
- Facilitate system risk assessments and ensure identified risks are appropriately documented and mitigated.
- Coordinate deviation management, CAPA activities, change controls, and compliance-related issue resolution.
- Ensure computerized systems meet data integrity and lifecycle compliance requirements.
- Collaborate with Quality, Validation, Engineering, Automation, IT, Laboratory, and Manufacturing stakeholders.
- Track validation deliverables, compliance milestones, risks, dependencies, and project status.
- Support regulatory inspections and internal or external audits when required.
Requirements
- Strong hands-on experience in Computer System Validation within a GMP-regulated pharmaceutical or manufacturing environment.
- Experience validating computerized manufacturing, automation, or laboratory systems.
- Strong knowledge of:
- GxP and data integrity requirements
- Computer System Validation and Computer Software Assurance
- Validation lifecycle management
- Software Development Life Cycle
- IQ, OQ, and PQ qualification
- Risk-based validation
- Change control
- Deviations and CAPA
- System lifecycle and compliance management
- Experience developing, reviewing, and approving validation protocols, reports, risk assessments, traceability documentation, and other compliance deliverables.
- Familiarity with FDA requirements, including 21 CFR Part 11, and relevant pharmaceutical industry regulations and guidance.
- Strong stakeholder-management, documentation, communication, and project-coordination skills.
- Ability to work onsite in West Point, Pennsylvania, twice per week.
Relevant Technology Exposure
Experience with at least one of the following manufacturing or laboratory platforms is required:
- DeltaV DCS
- Rockwell and/or Siemens PLC systems
- Process historians
- Laboratory automation systems
Preferred Profile
- Previous experience supporting pharmaceutical manufacturing or laboratory capital projects.
- Ability to provide independent compliance guidance to technical and business stakeholders.
- Experience working across Quality, IT, Engineering, Automation, Manufacturing, and Laboratory functions.
- Availability to join at short notice.
Benefits
- Location: USA – West Point, Pennsylvania
- Contract Type: Freelance / Contract
- Start date: September, 2026
- Time Allocation: 40 hours/week
- Pharmaceutical industry