Senior CSV Engineer 1202
SimoTech require a number of Senior CSV Engineers for a large Pharmaceutical project with a client based in Meath. Candidates will ideally have 5+ years’ experience in Life Sciences. The successful candidates will be responsible for the creation of bespoke validation packages that comply with current good manufacturing practices, regulatory requirements and site-specific validation and quality-related procedures.
- Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirements specifications, risk assessments, qualification protocols, requirements traceability matrices and validation reports.
- Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
- Perform business analysis activities.
- Ensure that computer systems and its associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
- Plan, organise and prioritise own workload and assist other team members in doing so, in order to achieve agreed objectives and ensure all relevant deadlines are met.
- Be supportive and encouraging of others in the team, showing flexibility in the delivery of team results.
- 5+ years CSV experience in either the Biotech or Pharma industry.
- Minimum of a Bachelor’s Degree in computer science, automation, software engineering, or other related subjects.
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11 is required.
- Strong knowledge of computerised system development life cycle.
- Experience of coordination of quality documentation and qualification/validation documentation.
- Strong technical writing and communication skills.
What SimoTech Can Offer
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting capital projects.
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