CSV Lead – Manufacturing Systems

futureproof

3d•Hybrid

About The Position

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.

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.

Nice To Haves

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.

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.