CSV Engineer

As the Senior CSV Engineer for the project, you will provide clear direction for the systems validation approach within the project Align with the validation strategy: leverage existing documents and expertise where feasible Assessing the validation impact of changes made to qualified systems Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy Develop templates for all SLC deliverables, compliant with standards, to ensure consistent implementation of the validation strategy, including but not limited to: User Requirements Specification (URS) Functional Specification (FS) Design Specification (DS) Test specification/test script Protocols (IOQ) Work closely with our QA & Compliance function and ensure their requirements are met in all deliverables. Provide FAT/SAT oversight and perform leveraging assessments Provide guidance and support to team members tasked with the delivery of SLC documents Provide input to the development of realistic project schedules and document trackers Qualification: Minimum of a Computer Science or Engineering/Science Degree with minimum 6+ years' experience in a Pharmaceutical or equivalent type industry Above 8 years of computer System Validation experience including Senior / Lead experience. GAMP CSV skills on Automation Process control systems (PCS) such as; o Data Historian (OSI Pi) o Equipment Serialisation, o SCADA and PLCs on Vendor Packaged Equipment (VPE) Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Reporting) Skills: Vaidation EU work permit system validation CSV OSI PI Historian