CSV Laboratory Equipment Qualification Specialist

il y a 1 jour


Paris, Île-de-France Optimus Life Sciences Temps plein
Job Title:

CSV Laboratory Equipment Qualification Engineer

Job Summary:

Optimus Life Sciences is seeking an experienced CSV Laboratory Equipment Qualification Engineer to join our team in Toulouse, France. As a key member of our CQV team, you will be responsible for generating and executing qualification/validation documents for computerized systems linked to laboratory equipment at a high-profile client site.

Responsibilities:
  • Generate validation documents for laboratory equipment systems, including URS, Risk Assessments, Data Integrity Assessments, and Protocol IOQ.
  • Work with equipment such as Mass Spectrophotometers, Cellometers, Electrophoresis equipment, Infrared Spectrophotometers, Colony Counters, PCR systems, Protein Simple Analysers, and Thermostatic Chambers.
  • Support the resolution of qualification non-conformities through investigation, assessment, and CAPA proposals.
  • Collaborate with the CQV team to execute qualification protocols related to computerized systems.
  • Ensure all deliverables are in accordance with GMP and other applicable regulatory standards.
Requirements:
  • 5-10 years of experience in validating computerized systems linked to laboratory equipment.
  • Proficiency in writing URS, Risk Assessments, and IOQ protocols.
  • Hands-on experience with laboratory equipment including Mass Spectrophotometers, Cellometers, Electrophoresis, Infrared Spectrophotometers, Colony Counters, PCR systems, Protein Simple Analysers, and Thermostatic Chambers.
  • Strong analytical and problem-solving skills, with a focus on delivering high-quality results.
  • Ability to work independently and collaborate effectively with a multidisciplinary team.
Eligibility:

Eligibility to work in the EU is required.



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