Csv Engineer - Toulouse, France - Contract (6months+)

  • Toulouse
  • Optimus Life Sciences
Job Title: CSV SpecialistLocation: Toulouse, France (On-site)Employment type: FreelanceContract length: 6 months (extension possible)Rate: NegotiableAbout Us:My client is a leading pharmaceutical manufacturing company searching for an experienced CSV (Computer System Validation) Specialist to join the team on a freelance basis. To be considered for this role, please apply belowResponsibilities:Execution of computerized systems qualification associated with production equipment (Delta V, QBMS, ...)Develop and execute CSV protocols, including validation plans, risk assessments, and validation reports.Ensure compliance with GMP, FDA, EMA, and other relevant regulatory requirements.Review and approve system documentation, including user requirements, functional specifications, and design specifications.Execute validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Execute computerized systems qualification associated with production equipment, including Delta V, QBMS, and other relevant systems.Collaborate with cross-functional teams including IT, production, quality assurance, and project management to ensure seamless project execution.Conduct risk assessments and implement corrective actions as necessary.Prepare and review documentation including validation plans, protocols, reports, and Standard Operating Procedures (SOPs).Train and mentor junior staff on CSV best practices and regulatory compliance.Requirements:Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field. Advanced degree preferred.Minimum of 3 years of experience in CSV within pharmaceutical manufacturing.Minimum of 2 years of experience in CSV documentation creation and review for IQ, OQ.In-depth knowledge of GMP, FDA, EMA, and other regulatory guidelines.Proven track record of successfully leading CSV projects from initiation to completion.Excellent written and verbal communication skills.Ability to work independently and as part of a team in a fast-paced environment.Note: Eligibility to work in the EU is requiredIf you wish to be considered for this role, please apply below using the Easy Apply with a copy of your updated resume and your contact number. If you have any questions, please don't hesitate to reach out at jherod@optimussearch.com