Back to the previous pageCommissioning & Qualification Lead
Location:
Switzerland
Salary:
€100 per hour
Job Type:
Contract
Date Posted:
7 days ago
Expiry Date:
11/05/2025
Job Ref:
BH-120227-1
Start Date:
27/03/2025
Contact:
Elvina Hasani
Contact Email:
elvina.hasani@earthstreamglobal.com
Specialism:
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
- 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.)
- Minimum of 10 Years extensive experience in CQ 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.
- Field CQV execution experience.
- Considerable experience with cGMP
- Strong interpersonal and communication skills.
- Good Level in English, written and spoken / German a plus.
- Experience in use of Kneat for documentation development and execution (not mandatory)
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