Commissioning and Qualification Engineer
Vue: 159
Jour de mise à jour: 25-04-2024
Catégorie: Haute technologie Mécanique / Technique Electrique / Electronique Conseil / Service client Production/Opération
Industrie: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing
Niveau: Mid-Senior level
Type d’emploi: Full-time
le contenu du travail
Responsibilities
- Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation).
- Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners
Requirements
- BSc/MSc Degree in Engineering, Chemistry or any related field.
- Working experience within pharmaceuticals, biotechnologies or chemical industry.
- Know-how of commissioning and qualification requirements according to (c)GMP regulations.
- Know-how of quality assurance principles and experience working with cross-department stakeholders.
- Experienced with GAMP5: Risk-based Approach to Compliant GxP Computerized Systems.
- Know-how of ISPE baseline guide vol 3, vol 4 and vol 5 is a plus.
- Fluency in English is required, German is a plus.
If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful.
Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.
Capgemini Engineering is an EEO and Affirmative Action Employer of Females/Minorities/Individuals with Disabilities.
Our offer
- A permanent contract with the leader in innovation and high-tech engineering consulting.
- A multi-stage model with career opportunities through specialization prospects with over 250’000 consultants around the world and a Group revenue of EUR. 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D).
- In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva.
- Trust-based managerial culture.
- Team rituals and get togethers.
- Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.
Date limite: 09-06-2024
Cliquez pour postuler pour un candidat gratuit
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