freelance
Validation/ CSV Engineer Reference number: 1378
Last update: 03-04-2020, 11:41
Region: Braine L'Alleud
Sector: Pharmaceutical
Job description
Validation/CSV position dedicated to the OS update of laboratory equipment from windows XP & Windows 7 to Windows 10.
The Engineer will work as part of the OS upgrade project on laboratory equipment.
What you’ll do
  • Participate to the Windows upgrade project (XP/7 to version 10) and bring insight/added value to the project
  • Write protocols and reports related to the migration projects
  • Perform testing of the validation protocol at the IQ/OQ/PQ phase
  • Coordinate with the R&D IT team and external third-party companies when necessary for some of the validation steps (IQ/OQ/PQ)
  • Notify management and project leader of any issues/bottlenecks
  • Deploy constant efforts reaching due dates, targets and milestones to ensure a successful project result
  • Able to manage its tasks on his own with minimal supervision
Profile
  • At least one previous experience in validation of analytical instrument (laboratory equipment) in a pharmaceutical environment.
  • Previous experiences in manipulating/testing/using analytical software for analytical instruments
  • Knowledge of the validation process (GAMP5 approach) and related documents
  • Knowledge of laboratory equipment e.g. GC-MS, Particles Counter (PMS, Accusizer, Malvern), AAS, ICP (AES/OES/MS), electronic and focal microscope
  • Experienced in data integrity i.e. 21 CFR part 11 from FDA and similar EU regulations
  • Previous experience working in a cGMP environment required. Knowledge of associated GDP rules is mandatory.
  • Team spirit and good communication skills
Required Skills
  • At least one previous experience (1 year) in validation of analytical instrument (laboratory equipment) in a pharmaceutical environment.
  • Minimum 3 years after high school
  • Good English level (at least full professional capacity i.e. reading, writing documents).
  • Minimum of 4 years of total overall experience
Interested? Send us your resumé
To apply for this job, please complete the form below and join your resume. This instantly places your information into our database. Once we have received your information, we will be in touch by e-mail or phone. If you have not heard from us after 3 working days, please call us!

Thank you for your interest in working with Harvey Nash and we look forward to assisting you in your job search!

Only PDF, max. 10MB

Only PDF, max. 10MB