CSV Laboratory Equipment Qualification Specialist
il y a 1 jour
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.
- 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 to work in the EU is required.
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