CSV Lead – USA

Futureproof; West Point (MS); On-site; USD 90,000 - 130,000; Full time

Job summary

Futureproof in West Point, PA is 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. You will lead validation lifecycle activities, guide cross-functional teams on GxP, CSA, and change control, and ensure data integrity.

The role partners with Quality, Validation, Engineering, IT, and Manufacturing, supports IQ/OQ/PQ documentation, risk

Qualifications

• 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; CSV and CSA; 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.

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.

Skills

GxP compliance

CSV expertise

Validation lifecycle

IQ/OQ/PQ qualification

Risk-based validation

Change control

Deviations & CAPA

Data integrity

Stakeholder management

Tools

Rockwell PLC

Siemens PLC

Process historians

Laboratory automation systems

Job description

West Point, United States

Data, analytics and cybersecurity staffing. We connect professionals and companies to deliver successful projects.

Job Description

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:

• 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.