Experienced and skilled in Commissioning, Qualification and Validation? We are searching for a lead engineer for a healthcare manufacturing organisation!
Proclinical is seeking a dedicated CQV Lead for Fill & Finish operations. This role focuses on overseeing commissioning and qualification activities related to utilities and equipment, specifically for liquid and lyophilized vial filling lines, isolators, and autoclaves. Your expertise will contribute to the successful execution of these critical processes.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Oversee CQV activities in alignment with the C&Q Plan and Validation Plans.
- Plan and execute commissioning activities for designated areas or systems.
- Lead and coordinate efforts with C&Q EPC teams, Engineering, Operations, and external vendors.
- Develop and manage schedules for commissioning activities.
- Update Master C&Q Plan and supporting plans throughout the project lifecycle.
- Prepare commissioning test plans and specifications.
- Coordinate commissioning activities with construction and other disciplines such as HSE, Automation, Electrical, and Instrumentation.
Key Skills and Requirements:
- Proficiency in CQ for Fill and Finish operations and related utilities.
- Background in Mechanical or Chemical Engineering preferred.
- Experience with liquid and lyophilized vial filling lines.
- Understanding of cGMP and pharmaceutical contract manufacturing.
- Ability to calculate project resources, time, and costs.
- Experience as a CQV-Lead or Project Manager.
- Strong interpersonal and communication skills.
- Proficiency in English; German is a plus.
- Familiarity with Kneat for documentation (not mandatory).
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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