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As part of the C&Q team reporting to the C&Q Manager, the main area of responsibility will be the Fill and Finish Facility Building, containing:
* Filling and semi-stoppering (filling, dose control, closing (stoppering), sampling and rejection of vials) using Peristaltic and Piston pump dosing systems for Lyophilized vials
* Filling Isolator (Internal environment Grade A (Iso 5), HVAC system, H2O2 decontamination process and Glove integrity tester, Rapid transfer ports for transfer of materials)
* Lyophilizers with mass spectrometer and dedicated loading and unloading isolator each
* ATEC Stopper treatment station and loading arm into the isolator
The tasks pertaining to this area are
* Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans.
* Overall planning and execution of the commissioning activities related to allocated areas or systems.
* Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
* Planning and scheduling the commissioning activities according to the C&Q strategy and supporting Validation Plans.
* Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
* Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
* Coordinating the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)
Your Profile:
* Minimum of 10 Years extensive experience in CQV for Fill and Finish and related utilities.
* Preferably Diploma level degree in Mechanical or Chemical Engineering.
* Extensive experience with Liquid and Lyophilized vial filling lines
* Comprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP
* Experienced in calculating project-related resource needs, time, and costs
* Experienced as CQV-Lead and/or Project Manager
* Considerable experience with cGMP
* Fluent in English (German is a plus)
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Quality Assurance
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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