CQV Lead

Desired Skills: commissioning,qualification,validation,documentation

Summary:

The CQ Lead is primarily responsible for overseeing all CQ activities related to utilities and equipment for Fill and Finish within scope of the project, a Liquid and Lyophilized vial filling line, isolators, and autoclaves.

Key Accountabilities:

• 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.)

Education and Experience:

• 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)