CSV Lead Manufacturing Systems

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