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15970en
- Contract
- English, German
- Associate
- Engineering & Technical Services
- Bern
- Healthcare & Life Sciences
On behalf of our client, a leading international biotechnology company based in Bern, Swisslinx is looking for a Sterility Assurance Specialist. If this is you, you will be responsible for supporting creation and implementation of aseptic processes at the company's site in Bern.
Start Date: ASAP
Location: Bern
Workload: 100%
Work type: Hybrid
Duration: 12 months (extension possible)
Your mission:
- Support implementation of the aseptic Isolator Filling Line the client's site.
- Create and update procedures, risk assessments, concepts.
- Ensure adherence to global company procedures and standards.
- Support creation of the aseptic process validation concept for a new Isolator Filling Line and Lyophilisation process.
- Support creation of aseptic process validation reports, protocols and procedures.
Your background:
- Business level German and English language (mandatory).
- +5 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing.
- Degree in Life Sciences.
- Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.
- Extensive professional experience in aseptic process validation (Media Fill validation), aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning.
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
What's on offer:
- a 12 month contract, with possibility of extension
- a great opportunity to develop your career at a leading biotechnology company
- flexibility with a hybrid work model
If this sounds like you, apply down below or reach out directly to Hugo Palejowski, recruiter: hugo.palejowski@swisslinx.com
Start Date: ASAP
Location: Bern
Workload: 100%
Work type: Hybrid
Duration: 12 months (extension possible)
Your mission:
- Support implementation of the aseptic Isolator Filling Line the client's site.
- Create and update procedures, risk assessments, concepts.
- Ensure adherence to global company procedures and standards.
- Support creation of the aseptic process validation concept for a new Isolator Filling Line and Lyophilisation process.
- Support creation of aseptic process validation reports, protocols and procedures.
Your background:
- Business level German and English language (mandatory).
- +5 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing.
- Degree in Life Sciences.
- Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.
- Extensive professional experience in aseptic process validation (Media Fill validation), aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning.
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
What's on offer:
- a 12 month contract, with possibility of extension
- a great opportunity to develop your career at a leading biotechnology company
- flexibility with a hybrid work model
If this sounds like you, apply down below or reach out directly to Hugo Palejowski, recruiter: hugo.palejowski@swisslinx.com
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