Remote CSV Lead: EU Pharma Validation & Compliance
futureproof
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Benefits offered by this job
Job summary
futureproof is seeking an experienced Computer System Validation (CSV) Lead to provide validation and compliance leadership for computerized manufacturing systems in a regulated pharmaceutical setting. This remote role combines hands-on validation work with guidance on risk, documentation, and lifecycle management.
You will collaborate with Quality, Engineering, Automation, IT/OT, and project teams, support regulatory inspections, and drive consistent CSV/CSA practices across capital and
Qualifications
- Extensive hands-on CSV experience in GMP environments.
- Experience leading validation and compliance for computerized manufacturing systems.
- Knowledge of FDA/EMA expectations and ICH guidelines.
- Ability to develop and approve validation documentation.
- Strong communication and leadership skills.
Responsibilities
- Provide CSV/CSA validation and compliance support for manufacturing projects.
- Lead validation activities for computerized manufacturing and lab systems.
- Develop and approve validation lifecycle documentation per GxP and SOPs.
- Advise teams on CSV/CSA, SDLC, risk-based validation, IQ/OQ/PQ.
- Conduct risk assessments and determine validation strategies.
- Ensure ongoing compliance during system lifecycle and retirement.
- Collaborate with Quality, Engineering, Automation, IT/OT, and stakeholders.
- Support regulatory inspections and internal audits.
- Identify risks and implement mitigation measures.
- Promote consistent CSV/CSA practices across projects.
Skills
Education
Tools
Job description
futureproof is seeking an experienced Computer System Validation (CSV) Lead to provide validation and compliance leadership for computerized manufacturing systems in a regulated pharmaceutical setting. This remote role combines hands-on validation work with guidance on risk, documentation, and lifecycle management.
You will collaborate with Quality, Engineering, Automation, IT/OT, and project teams, support regulatory inspections, and drive consistent CSV/CSA practices across capital and
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