CQV engineer

Join a dynamic team at a leading Contract Manufacturing Organisation (CMO) and contribute to groundbreaking projects and cutting-edge solutions.

Proclinical is seeking a CQV Engineer to join our client's team on a contract basis. In this role, You will focus on the qualification of machinery and infrastructure, ensuring compliance with cGMP requirements. Your work will involve coordinating equipment installation, drafting and executing IQ/OQ/PQ protocols, and documenting results. This position requires a proactive approach to improving validation processes and staying updated on industry regulations.

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:

• Coordinate installation and validation of equipment and facilities.
• Draft and execute IQ/OQ/PQ protocols.
• Document validation results according to cGMP standards.
• Prepare and manage validation documentation including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols.
• Conduct GAP Analysis and Risk Assessment.
• Identify efficiencies in validation programs and apply lessons learned.
• Stay informed on regulatory changes affecting equipment/facility validation.
• Perform Quality Systems activities such as Document Management, Change Control, Non-Conformities, and CAPA's.
• Write and revise procedures related to engineering activities.
• Support the preparation of validation, requalification, and maintenance programs.
• Perform other duties as assigned.

Key Skills and Requirements:

• Bachelor's Degree in Science or Technical field.
• Fluency in German and English.
• Strong technical writing skills for thorough and accurate documentation.
• Excellent communication skills for effective interdepartmental collaboration.
• Strong organizational and time management abilities.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

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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