QA Computer Systems Validation (CSV)
Location: Dublin, Ireland
Contract Duration: 12-month contract ( Hybrid)
Rate: €539.00 Daily
A leading global biopharmaceutical organisation is seeking a QA Computer Systems Validation (CSV) Specialist to support a major sterile drug product start-up project.
This role will be part of the QA Technical Operations team, working closely with CSV, CQV, Automation, and Engineering to ensure systems and equipment are delivered in line with GMP and regulatory requirements. The position will support all phases of the project, from design and construction through to qualification and operational readiness.
Key Responsibilities
- Support QA activities across design, build, commissioning, and qualification (CSV/CQV) phases
- Review and approve validation documentation, SOPs, deviations, CAPAs, and change controls
- Collaborate with CSV, CQV, Automation, and Engineering teams to ensure compliant system delivery
- Support GMP design reviews and contamination control strategies for sterile manufacturing
- Contribute to start-up and operational readiness activities
- Drive continuous improvement initiatives (5S, Kaizen, problem solving)
- Ensure compliance with GMP, data integrity, and regulatory standards
Requirements
- Degree in Engineering, Science, or related discipline
- Minimum 5 years' experience in a GMP pharmaceutical/biologics environment
- Strong experience in CSV and QA validation activities
- Exposure to sterile drug product / aseptic manufacturing environments
- Experience with:
- Validation lifecycle (URS to PQ)
- Deviations, CAPAs, and change controls
- EU Annex 1 and contamination control strategies
- Strong communication, organisation, and stakeholder management skills
Desirable Experience
- Start-up / greenfield project experience
- Exposure to fill-finish operations (vials, syringes, lyophilisation)
- Experience with systems such as LIMS, MES, SCADA, DeltaV, or Empower
We're actively shortlisting, apply now or get in touch today to avoid missing out!!
