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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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