Process validation specialist

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

Proclinical is seeking a Process Validation Specialist for a contract role in Switzerland. This position focuses on designing and implementing process validation strategies, preparing necessary documentation, and ensuring compliance with regulatory standards. The role requires collaboration with R&D teams and involves reviewing and approving process-related documents.

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:

• Design process validation strategies and prepare validation documents, including study designs, protocols, and reports.
• Support R&D teams during the process characterization phase.
• Review and approve process characterization documents.
• Conduct validation assessments on changes and deviations, including approval processes.
• Prepare and maintain a detailed continued process verification plan.
• Assess and approve Product Quality Reviews.

Key Skills and Requirements:

• Advanced degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or a related field.
• Experience in project management, particularly in Operations, MSAT, Quality, and Compliance.
• Ability to interact with various collaborators and regulatory agencies is advantageous.
• Familiarity with mammalian processes is beneficial.
• Strong multitasking skills and ability to meet deadlines.
• Proficient in English; German proficiency is appreciated.
• Hybrid work option available: 2 days home office, 3 days onsite.

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

Apply Now:

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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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