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Job Description
Senior Computerised System Validation Engineer
As Senior Computerised System Validation Engineer, you will provide clear direction for equipment systems validation approaches within the organization. Reporting into the Design Assurance Manager and working as part of the wider QARA team, you will excel through cross functional partnering, individual development planning, training and encouragement to progress your career.
Key Responsibilities:
- Applying a Risk-based, best-practice approach to validation strategies.
- Assessing the validation impact of changes made to the systems/equipment, Assessing 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.
Qualifications & Experience:
- A Computer Science, Engineering or Science Degree.
- Minimum 6+ years CSV as a Senior / Lead in a Pharmaceutical or relevant industry.
- Understanding of ISO 13485 and FDA/ISO, 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.
- Understanding of CSA (Computer Software Assurance) per FDA guidance desirable.
Beneficial Experience:
- Software Development Lifecycle (SDLC).
- Implementation and Validation of ERP systems.
- System Administration.