About the Role
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* Authoring and managing automation documentation, including C&Q plans, PCS automation validation plans, URS, FAT, IOQ documentation, and summary reports in collaboration with cross-functional teams.
* Monitoring FAT and IOQ execution activities, ensuring alignment with test script intent, identifying, and resolving protocol issues and executing CSV-related tests on lines and equipment.
* Ensuring all automation deliverables comply with regulations and industry best practice standards.
* Maintaining consistency and traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, STQM/RTM, and summary reports.
* Identifying risks and recommending improvements to the C&Q and automation qualification strategy, documentation quality, and test execution.
* Sharing key learnings to facilitate effective knowledge transfer for future projects.
Your Qualifications
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, and 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.
Experience working with paperless validation systems would be an advantage.
Demonstrate excellent interpersonal and communication skills, with strong attention to detail and the ability to work effectively across cross-functional teams.
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