Senior Computerised System Validation Engineer required by growing MedTech company in Galway to act as a Subject Matter Expert (SME) for Validation Compliance of Computerized Systems in Audits. Reporting to the Design Assurance Manager and with a QA / RA team, you will also train, develop and manage CSV engineers.
Responsibilities:
* Apply a Risk-based, best-practice approach to validation strategies.
* Assess the validation impact of changes made to the systems/equipment, assess 21CFR Part 11 requirements.
* Ensure that processes, SOPs and forms for computerised systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
* Develop & maintain Qualification and Test Plans, aligned with the overall project plan.
* Develop documentation templates, ensuring compliance with standards, to implement the validation strategy for URS, Traceability Matrix, FS, DS, Test Scripts.
* Develop and review computer validation/assurance documentation (Validation Plan, IQ, OQ, PQ).
* Provide input into FAT/SAT execution and carry out leverage evaluations.
* Contribute to the development of project schedules and document trackers.
* Coordinate with project stakeholders to make them aware of Validation requirements.
* Work closely with Vendors, Suppliers, and System Integrators.
* Train, develop and manage CSV engineers to ensure objectives are communicated and delivered per business requirements.
* Act as a Subject Matter Expert (SME) for Validation Compliance of Computerized Systems in Audits.
* Maintain SME knowledge in validation (computerised systems) across all levels at the site, ensuring compliance with current industry regulations, guidelines, and trends.
Requirements:
* BSc. Degree in Computer Science or Quality Assurance, or equivalent industrial experience.
* At least 6 years’ experience working as a Lead or Senior Computer System Validation within pharma or medical devices.
* Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Parts 11 & 820.
* Experience with reviewing computer validation documentation (Validation Plans, IQ, OQ, PQ, RTM, Reporting.)
* Familiarity with GAMP5 Guideline for “Risk Based approach to GxP Compliant Computerised systems.”
Ideal:
* Understanding of CSA (Computer Software Assurance) per FDA guidance.
* Software Development Lifecycle (SDLC).
* Implementation and Validation of ERP systems.
* System Administration.
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