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Validation Engineer


  • A hirdetés 1025 napja lejárt
For one of our partners, a biotechnology company based in French-speaking Switzerland, Kelly Scientific is looking for a Validation Engineer.

Your tasks:

• Maintain Validation Master Plan for process, cleaning and packaging validation.
• Partner with Quality, engineering and IT to define the process validation / equipment / systems qualification interface.
• Apply the strategy for continued process verification (CPV) and annual monitoring batches that ensures all critical process parameters and quality attributes are monitored or analyzed, and actions taken in case of trends or deviation.
• Set local procedures & templates for respective validation documentation.
• Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections.
• Ensure that all site validation activities are performed and are in line with the current intern requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
• Translate the critical process parameters and the process control strategy into a focused validation plan for process validation
• Apply complex validation protocols (e.g. launches, transfers, weak point remediation).
• Author routine re-validation protocols and reports, reviews Master Batch Records (MBRs), associated change controls and execute at the shop floor.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach.
• Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Support equipment process qualification for new technologies.
• Ensure consistency with process needs defined by Manufacturing and/or Engineering.
• Provide input to Quality Manuals (QM) / Quality Directives (QD) / global standard Operating Procedures (SOPs) and technical Guidance Documents (TGDs) to ensure the document is in line with global / local requirements and industry standards.
• Apply continuous improvement methods such as problem solving, 5S.

Your profile:
• Degree in Engineering in pharmaceutical, chemical, cosmetic processes, industrial pharmacist
• Knowledge in semi solids formulation is an asset
• Fluent in French / English
• 1-3 yrs experience in a Consumer Goods or Pharmaceutical manufacturing/technical environment.
• Proven experience in product process validation, in cleaning validation and processing
• Fundamental understanding of standard pharmaceutical analytical testing

Should your profile match our requirements, please contact:
Marina Leroy - PhD in Biology - Scientific Recruitment Consultant
Kelly Scientific - Geneva

Region: Vaud
Vertragsart: Befristet
Kategorie: Ingenieurwesen/Entwicklung/Konstruktion;
Gesundheitswesen;
Produktion/Operationen;
Qualitätswesen;
Naturwissenschaft/Forschung
Veröffentlicht am: 29.09.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1409-16096
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