Be the driving force behind seamless engineering for a global CMO, where precision and efficiency are key to supporting world-class manufacturing.

Proclinical is seeking a CQV Engineer to support validation activities for equipment, systems, and facilities. This role involves drafting and executing protocols, documenting results in compliance with cGMP requirements, and contributing to quality systems processes. The position requires full-time onsite presence in VISP and fluency in German and English.

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 equipment installation and draft IQ-OQ-PQ protocols.
• Execute IQ-OQ-PQ protocols and document results per cGMP standards.
• Prepare validation documents, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols.
• Conduct process gap analysis and risk assessments.
• Write reports on completed validation activities.
• Identify efficiencies in validation program approaches and apply lessons learned.
• Stay informed of industry regulatory changes related to equipment and facility validation.
• Perform quality systems activities such as document management, change control, non-conformities, and CAPAs.
• Write or revise procedures relevant to engineering activities.
• Support the engineering team in validation, requalification, and maintenance programs.
• Perform other duties as assigned.

Key Skills and Requirements:

• Fluent in German and English.
• Bachelor's degree in Science or a Technical field.
• Strong technical writing skills for thorough and accurate documentation.
• Excellent written and oral communication skills for effective interdepartmental collaboration.
• Strong organizational and time management abilities.
• Familiarity with quality systems processes and regulatory standards.
  

If you are having difficulty in applying or if you have any questions, please contact Emile De Beer at e.debeer@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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