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Life Science Automation Specialist
3 weeks ago
Specialists in life science automation and IT systems are required to work on critical process automation systems.
The ideal candidate will have a strong understanding of pharmaceutical design, build, commissioning, and validation processes, and their alignment with EU and US FDA regulatory requirements.
Key Responsibilities- Author and manage the C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports, in collaboration with cross-functional teams.
- Monitor FAT and IOQ execution activities, ensuring alignment with test script intent, identifying & resolving protocol issues and executing CSV related tests on lines and equipment.
- Ensure all automation deliverables comply with regulations and industry best practice standards.
- Maintain consistency and traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, STQM/RTM and summary reports.
- Identify risks and recommend improvements to the C&Q and automation qualification strategy, documentation quality, and test execution.
- Bachelor's degree in engineering, computer science, life sciences or similar.
- Minimum 3 years' experience in GMP and validation disciplines, with a strong understanding of pharmaceutical design, build, commissioning, & validation processes, and their alignment with EU and US FDA regulatory requirements.
- Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
- Experience working with one or more of the following systems: MES, PI Data Historian, PCS, Lab systems, QBMS, or inspection line control systems.
- 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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