Process Validation Specialist at Hays (Schweiz) AG (Berne, BE, Switzerland) | Careerkit Jobs
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Hays (Schweiz) AG·Pharmaceuticals·Berne
Process Validation Specialist
PosteDurée déterminée · Mid · Ingénierie
RémunérationAttractive salary package
ExigencesBachelor · Permis UE/AELE
Votre correspondance
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Compétences
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BiotechnologyTechnical writingBioprocessing knowledgerisk assessmentsQuality control in constructionGood Manufacturing Practice (GMP)Change Control RecordsTechnical deviation analysisCross-Functional LeadershipChemistry expertiseArchitectureMethod validation
Langues
Anglais
Rémunération
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Attractive salary package
Le poste
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01* Support execution of process validation activities for biotech manufacturing processes
02* Prepare, update, and finalize process validation protocols and reports, with a strong focus on completing outstanding validation documentation
03* Coordinate sampling activities and support shop floor execution in collaboration with Manufacturing and Quality Control
04* Assist with deviation investigations, change controls, and risk assessments related to validation activities
05* Ensure validation documentation complies with cGMP and internal quality requirements
06* Contribute to Continued Process Verification (CPV) documentation and other validation-related deliverables as needed
07* Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, and MSAT
Exigences
↳* Bachelor's or Master's degree in Life Sciences, Biotechnology, Chemistry, Engineering, or related discipline
↳* Strong experience in process validation within a GMP pharmaceutical or biotech manufacturing environment
↳* Strong technical writing skills, with demonstrated experience authoring validation protocols and reports
↳* Knowledge of upstream and/or downstream bioprocessing is preferred
↳* Working knowledge of cGMP and validation lifecycle principles
↳* Ability to work independently while supporting a broader validation team
