Long-term Contract
CQV Expert
German Speaking atleast B2 level
The ideal candidate will have extensive hands-on experience in the pharmaceutical industry, particularly with the CQV full lifecycle for new and upgraded manufacturing systems and equipment. This role is crucial for ensuring that all systems meet cGMP standards and are ready for safe, compliant, and efficient operation.
Key Responsibilities:
* Hands-on CQV Execution:
Directly perform and manage CQV activities from planning through to execution. This includes authoring, reviewing, and executing protocols for commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
* Protocol & Report Generation:
Write and approve detailed CQV protocols, summary reports, and other technical documents. Ensure all documentation is accurate, complete, and compliant with regulatory guidelines (e.g., FDA, EMA).
* System & Equipment Expertise:
Apply deep technical knowledge to a variety of pharmaceutical systems, including but not limited to, process vessels, utility systems (WFI, clean steam, compressed air), sterilization equipment (autoclaves), and fill/finish lines, reactors, centrifuges, mixers, dryers, filters, etc.
* Deviation & Investigation Management:
Lead investigations into protocol deviations and non-conformances. Use a hands-on approach to troubleshoot issues, determine root causes, and implement corrective and preventive actions (CAPA).
* Cross-Functional Collaboration:
Work closely with engineering, manufacturing, quality assurance, and project management teams to ensure a smooth transition from project completion to validated operation.
* Vendor Management:
Interface with and oversee third-party vendors and contractors performing CQV-related tasks.
Required Qualifications:
* Experience:
Minimum of 5-10 years of hands-on CQV experience within the pharmaceutical or biotechnology industries.
* Technical Skills:
Proven expertise in authoring and executing validation protocols (IQ/OQ/PQ) and a strong understanding of cGMP principles.
* Education:
Bachelor's degree in a relevant scientific or engineering discipline (e.g., Chemical Engineering, Mechanical Engineering, Biotechnology).
* Regulatory Knowledge:
In-depth knowledge of global regulatory requirements, including FDA 21 CFR Parts 210, 211, and relevant Annexes of the EU GMP Guide.
* Soft Skills:
Excellent problem-solving, communication, and technical writing skills. Must be a self-starter who can work independently and manage multiple tasks in a fast-paced project environment.
If interested, apply here with the latest CV or send it on
CQV
Commissioning
Qualification
Pharmaceuticalengineering
ISPE
GMP
Contractjobs