CSV Engineer

Summary:   

Our client, a biopharmaceutical manufacturing company located in Meath, is seeking a CSV Engineer. The successful candidate will ensure systems and processes operate in accordance with applicable regulatory, quality, data integrity and safety standards. This role will support inspection readiness, governance of computerised systems, quality system execution and operational compliance across the site. Responsibilities include oversight of compliance deliverables, coordination of quality and engineering systems, participation in investigations, and ensuring adherence to industry frameworks.

Responsibilities:

• Ensure ongoing inspection readiness within the operations and engineering teams.
• Generate, review and approve Computer System Assurance (CSA) documentation and related compliance deliverables.
• Provide compliance coaching and support to team members on GxP, data privacy, financial controls and data integrity requirements.
• Manage deployment of global and site policies related to system lifecycle management, CSA and IT security.
• Ensure all compliance elements required to support operational activities are in place, including change control, periodic reviews, system administration, access management, disaster recovery, deviations, investigations, CAPAs, audits, cyber security and EHS-related requirements.
• Support delivery of quality and compliance objectives, ensuring high standards in GxP, EHS and data integrity.
• Participate in tiered meetings, proactively escalating and resolving issues as needed.
• Collaborate with other compliance personnel across the site and support site-wide quality initiatives and governance forums.
• Coordinate change controls, EHS activities and compliance metrics relevant to automation, IT and engineering systems.
• Lead or support investigations, performing root-cause analysis and developing effective CAPAs.
• Contribute to project delivery and operational readiness activities through strong planning and organisational skills.

Qualifications & Experience:

• Degree in Science, Engineering or another relevant technical discipline.
• Lean Six Sigma Green Belt preferred.
• Project management or computer validation training is desirable.
• Minimum 2 years’ experience in CSV/CSA activities within a GMP biologics or pharmaceutical manufacturing environment.
• Strong understanding of regulatory requirements for computerised systems, including data integrity principles and industry guidance (e.g. EU GMP Annex 11, 21 CFR Part 11).
• Knowledge of data integrity frameworks, including MHRA and PIC/S guidance.
• Experience with PLC, SCADA, DCS or similar automation/IT systems is beneficial.
• Familiarity with deviation management, change control, CAPA systems, audit processes and quality risk management.