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FrankreichManufacturing Technology Transfer Expert (m/f/d), France
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Elektrotechnik
Technik
Technik
Ingenieur
Techniker
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Veröffentlicht seit 2 Tagen
Siemens
Premier groupe européen de haute technologie, Siemens conjugue depuis toujours performance technique, innovation, qualité et fiabilité.
Nos activités centrées sur les secteurs des infrastructures et des villes, l'industrie, l'énergie et la santé, ciblent des marchés de croissance sur lesquels le Groupe nourrit l'ambition d'être leader.
Tasks
- Lead end‑to‑end Technology Transfer projects, managing timelines, deliverables, and cross‑functional coordination: MS&T, Quality, TRD (Research & Development), Engineering, IT, suppliers, and external partners.
- Define qualification and validation strategies for new QC/production processes and equipment across Radiopharma network, in alignment with MS&T, Global Tech Ops, and Quality.
- Oversee the preparation and execution of qualification documentation (IQ/OQ/PQ) and ensure proper installation and validation activities.
- Drive technology scouting with Engineering to identify, source, and test new solutions that enhance process efficiency while meeting Safety, GMP, and Annex 1 requirements.
- Ensure strong collaboration and stakeholder alignment throughout the project lifecycle — from initiation and planning to execution and close‑out.
- Support and contribute to training activities for new equipment, methods, and processes.
- Ensure site readiness post‑transfer, covering equipment, methods, and processes.
- Participate in local/global change control and implementation of action plans.
- Contribute to SOP development for manufacturing and QC operations.
- Harmonize and distribute qualification documentation across PET manufacturing sites.
- Act as a Subject Matter Expert (SME) during GMP inspections and serve as a key point of contact for your scope.
- This role requires occasional travel across Europe, approximately one week per month.
Profile
- Bachelor’s or Master’s degree in Chemistry, Pharmacy, or any related field.
- Minimum 3 years experience in pharmaceutical production or quality control within highly regulated environments.
- Solid understanding of sterile process design and strong familiarity with EU GMP requirements — particularly Annex 1.
- Ability to understand and navigate complex technical activities, processes, and equipment.
- Excellent written and spoken English, with strong interpersonal skills that enable effective collaboration across diverse teams and stakeholders.
Apply
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