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, including 21CFR Part 11 requirements.
* Ensuring that processes, SOPs, and forms for computerised systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
* Developing & Maintaining Qualification and Test Plans, aligned with the overall project plan.
* Developing documentation templates to ensure compliance with standards for the 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.
* Contributing to the development of the project schedules and document trackers.
* Coordinating with project stakeholders to make them aware of Validation requirements.
* Working closely with Vendors, Suppliers, and System Integrators.
* Training, developing, and managing CSV engineers to ensure objectives are communicated and delivered per the business requirements.
* Acting as a Subject Matter Expert (SME) for Validation Compliance of Computerized Systems in Audits.
* Maintaining SME knowledge in validation (computerised systems) and ensuring compliance with current industry regulations, guidelines, and trends.
Qualifications & Experience:
* A Computer Science, Engineering, or Science Degree.
* Minimum 6+ years of CSV experience 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 is desirable.
Beneficial Experience:
* Software Development Lifecycle (SDLC).
* Implementation and Validation of ERP systems.
* System Administration.
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