In this role, you will oversee the GMP compliance of critical utilities and facility systems during the lifecycle of manufacturing projects. You will ensure that all validation activities and quality standards are maintained and documented according to regulatory requirements. Your expertise will support seamless project execution from design through qualification and handover.
Start Date: 04.08.2025
Duration: 6 Months
Place of Work: Stein (AG)
Key Responsibilities
* Ensure that Commissioning, Qualification, and Validation (CQV) plans for GMP systems are developed, executed, and compliant with quality policies and SOPs
* Qualify and approve vendors involved in the project
* Review and approve CQV plans, protocols, reports, and related documentation such as URS, FAT/SAT, IQ/OQ
* Provide quality oversight and guidance on CQV documentation and change controls
* Lead and support staff on qualification and validation issues
* Manage deviations, change controls, and CAPAs, taking ownership for timely resolution and escalation when necessary
Candidate Profile
* Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field
* Extensive experience in the GMP-regulated pharmaceutical industry, ideally within a Quality or Engineering function related to utilities
* Proven track record in QA and/or engineering roles focusing on Clean Utilities for aseptic fill-finish processes and facilities
* Languages: Fluent in English, German skills are a plus
Job ID 41180965
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