CSV Lead – Europe

This is a remote position. We are looking for an experienced Computer System Validation (CSV) Lead to provide validation and compliance leadership for computerized manufacturing systems within a regulated pharmaceutical environment. You will support capital and strategic projects, ensuring that manufacturing and laboratory systems remain compliant throughout their lifecycle. The role combines hands-on validation work with compliance guidance, document approval, risk management, and collaboration with engineering, automation, quality, and project teams.

• Provide CSV and compliance support for capital and strategic manufacturing projects.
• Lead validation activities for computerized manufacturing and laboratory systems.
• Develop, review, and approve validation lifecycle documentation in accordance with GxP requirements, internal SOPs, and regulatory expectations.
• Advise project teams on:
  • Computer System Validation and Computer Software Assurance (CSV/CSA)
  • Software Development Lifecycle (SDLC)
  • Risk-based validation
  • System qualification, including IQ, OQ, and PQ
  • Change control and configuration management
  • CAPA and deviation management
  • Data integrity and lifecycle compliance
• Conduct or review system risk assessments and determine appropriate validation strategies.
• Ensure compliance oversight throughout system implementation, modification, and retirement.
• Work closely with Quality, Engineering, Automation, IT/OT, laboratory, and business stakeholders.
• Support regulatory inspections, internal audits, and remediation activities when required.
• Identify compliance risks and ensure that appropriate mitigation measures are implemented.
• Promote consistent CSV/CSA practices across manufacturing projects and systems.

• Strong hands-on experience in Computer System Validation within GMP-regulated pharmaceutical or manufacturing environments .
• Experience supporting validation and compliance activities for computerized manufacturing systems .
• Strong knowledge of:
  • Validation lifecycle management
  • CSV and CSA principles
  • GxP and GMP requirements
  • SDLC
  • IQ/OQ/PQ qualification
  • Change control
  • CAPA and deviation management
  • Risk-based validation and risk management
  • Data integrity requirements
• Demonstrated experience developing, reviewing, and approving validation documentation and compliance deliverables.
• Understanding of relevant FDA, EMA, and international regulatory expectations.
• Ability to provide compliance guidance and challenge project teams when necessary.
• Strong stakeholder-management, communication, and leadership skills.
• Professional fluency in English.

• DeltaV Distributed Control Systems
• PLC systems , particularly Rockwell and/or Siemens
• Process historians
• Laboratory automation systems
• Other GxP-regulated manufacturing automation or IT/OT platforms

• Previous experience acting as a CSV Lead, Validation Lead, or senior compliance representative on complex manufacturing projects.
• Experience supporting capital projects within pharmaceutical production facilities.
• Familiarity with current CSA and risk-based validation approaches.
• Experience working in international, cross-functional project environments.
• Knowledge of manufacturing automation architecture and IT/OT system integration.

The ideal candidate combines deep CSV expertise with practical knowledge of pharmaceutical manufacturing systems. You can independently assess compliance risks, approve validation deliverables, and provide clear guidance to technical and business teams throughout the complete system lifecycle.

• Location:
  
  Remote in EU
• Contract Type:
  Freelance / Contract
• Start date:
  
  September, 2026
• Time Allocation: 40 hours/week
• Pharmaceutical industry

Originally posted on Himalayas