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, making sure to stay compliant with standards, to ensure implementation of the validation strategy for URS, Traceability Matrix, FS, DS, Test Scripts
• Development and review of computer validation/assurance documentation (Validation Plan, IQ, OQ, PQ)
• Providing input into FAT/SAT execution and carrying out leverage evaluations
• Contribute to the development of the project schedules and document trackers
• Coordinate with project stakeholders making 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 the business requirements
• Act as a Subject Matter Expert (SME) for Validation Compliance of Computerized Systems in Audits
• SME knowledge in validation (computerised systems) and 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 in 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