Labs CSV Engineer 1203
SimoTech require a number of Labs CSV Engineers for a large Pharmaceutical project with a client based in Meath. The ideal candidate will have at least 3 years’ experience in Life Sciences.
- Draft test cases for QC laboratory systems.
- Establish and revise the Validation Plan for QC laboratory systems.
- Lead the risk assessment before test execution, this includes but is not limited to ERES assessment and functional risk assessments.
- Review vendor validation documents, including validation protocols and validation summary reports.
- Participate in deviation investigations, analysis and change assessment.
- Minimum of a Bachelor’s Degree in computer science, automation, software engineering, or other related subjects.
- At least three years’ CSV experience in Life Sciences, ideally within a laboratory environment.
- Significant knowledge of regulatory requirements relating to CSV and Data Integrity including 21 CFR Part 11.
- Basic knowledge of Analytical chemistry/Biochemistry.
- Basic knowledge of IT network, domain control and database.
- Excellent communication, problem-solving, and organizational 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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