The CSV Engineer will manage the validation of GMP-critical computerised systems to ensure compliance with regulatory requirements and data integrity standards. The role supports the full system lifecycle from design through to qualification and operation.
Responsibilities
:
* Develop and execute CSV deliverables in line with GAMP 5, Annex 11 and 21 CFR Part 11.
* Support validation activities for MES, LIMS, ERP, automation and other GMP-critical systems.
* Author and review validation plans, risk assessments, protocols and reports.
* Work closely with IT, QA and engineering teams to ensure system compliance throughout lifecycle.
* Manage deviations, CAPAs and change controls associated with computerised systems.
* Provide support during internal audits and regulatory inspections.
Requirements
:
* Degree in Engineering, Computer Science or a related discipline.
* 3–5 years' experience in CSV within the pharmaceutical or biotechnology sector.
* Strong understanding of GAMP 5, Annex 11 and 21 CFR Part 11 requirements.
* Experience with validation of MES, LIMS, ERP or automation systems.
* Strong technical writing, problem-solving and stakeholder management skills