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Equipment Validation Expert

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Altran is a global engineering consultancy and leader in R&D Services (ER&D), offering its clients a new way to innovate by developing products and services of tomorrow. Being a consultant for Altran means working alongside our clients on every link in the value chain of their project, from concept stage to industrialization. The Altran Group provides its expertise to key players in the Life Sciences sectors for Medical Devices-, Implants-, Laboratory Equipment Systems-, Biotech & Pharmaceuticals-, and Medical Device Apps.

Currently we are looking for an

 

Equipment Validation Expert

 

Responsibilities and Duties

  • Lead the preparation, review and approval of the validation master plan
  • Prepare and perform Qualification and Validation activities in compliance with cGMP regulations and specification requirements
  • Write, Review and Execution of Qualification / Validation protocols (OQ, PQ).
  • Review and approval of third party generated protocols and reports
  • Demonstrate a general understanding of cell therapy manufacturing equipment and validation procedures for Clean Rooms, Aseptic Processing, Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment. 
  • Develop validation protocols from Validation plans and engineering documents.
  • Provide technical support when reviewing and approving SOPs, protocols, change controls, deviations.
  • Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.)

Requirements

  • BSc in Science or technical discipline intermediate or more years of industry experience
  • Good understanding of cell therapy manufacturing equipment and validation procedures for Clean Rooms, Aseptic Processing, Autoclaves, Clean Utilities, Temperature Mapping Controlled Storage Rooms and Equipment.
  • Solid technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
  • Experience with Quality Systems including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
  • Demonstrates ability to prioritize tasks as needed to support the changing business demands
  • Fluent English knowledge and good German is mandatory

 

If the position sounds interesting to you, and you have the necessary know-how, please send your application documents via E-Mail to our Recruitment Manager, Mr Martin Weber to martin.weber2@altran.com.

 

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.

 

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, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

  • In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.

Adresse

Altran AG
Herr Martin Weber
Recuitment Manager
Aeschenvorstadt 71

E-Mail

Website http://www.altran.ch

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