Laboratory System Specialist - Validation Engineer

☞ Manpower

View: 144

Update day: 20-04-2024

Location: Neuchâtel Neuchâtel NE

Category: IT - Hardware / Networking Information Technology

Industry:

Job type: 100%

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Seize the freedom to define your future by joining Philip Morris. We are currently looking for a Your mission
Duration : open-ended contract through Manpower Your profile


Overall responsibility is to validate laboratory instruments and software and more specifically to:

  • Act as validation engineer for the validation of laboratory instruments and software
  • Provide IT and validation expertise for computerized systems validation
  • Act as point of contact with the laboratories for planning of instrument validation activities for Preclinical Sciences & Toxicology department in Neuchatel
  • Develop or review documentation related to computerized system validation:
  • User Requirements and Functional Specifications
  • IQ/OQ/PQ/UAT test scripts and reports
  • Traceability matrices
  • SOPs/WKIs/User Guides
  • Organize and follow execution of IQ/OQ/PQ/UAT
  • Manage deviations
  • Act as point of contact with IT and QA for the implementation and validation of computerized systems
  • Provide business support for Scientific Data Management System (user training, request for instrument integration, request for folder creation…)
  • Approve access of users to SDMS
  • Perform the verifications to ensure that data is properly uploaded from laboratory workstations to the Scientific Data Management System or equivalent system
  • Support laboratory data management process

  • Master or Bachelor degree in science or computer science.
  • At least 3 years of experience in Computerized Systems Validation, data integrity (GAMP5, CFR21part11)
  • At least 3 years of experience with Laboratory systems (Instrument, analytical software, LIMS, SDMS, ELN, CDS)
  • At least 3 years of experience in the Life Sciences industry
The incumbent must perform him duties in accordance to Good Laboratory Practice (GLP) according to the RS 813.112.1 Ordonnance sur les bonnes pratiques de laboratoire (OBPL) du 18 mai 2005 (Etat le 12 juillet 2005) and the respective PMI procedures.
Interested?
Our success depends on the men and women who come to work every day determined and eager to progress. Send us your application and become part of PMI!
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Deadline: 04-06-2024

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