C&Q ENGINEER PHARMA H-F

Il y a 4 heures

Walloon Region, Walloon Region, Belgique EFOR Temps plein

TASKS & RESPONSABILITIES


In the context of investments projects (new or upgrades) in vaccines production, ensure proper execution of C&Q methodology and application of cGMP (Validation Master Plan, Design Qualification, Commissioning, Installation & Operational Qualification and Validation Reports).


  • Follow and coordinate the commissioning and qualifications during a project.
  • Review and ensure the compliance of the qualification protocols, review the commissioning and qualification raw data and finally approve the reports for conformance.
  • Must be able to advice the various actors in case of issues or deviations .
  • Has an expertise in all commissioning / qualification aspects of vaccine manufacturing such as qualifications of HVAC systems, Clean Utilities (Clean Compressed Air, Clean Steam, Purified Water, Water For Injection, ...), autoclaves, analytical systems, CIP/SIP process, filling lines, bulk equipments other equipment commonly used in vaccine manufacturing facilities and be able to manage most of these qualification aspects.
  • Ensure that all GMP aspects are respected during the project.
  • Able to manage the project respecting the established commissioning / qualification timelines and coordinate all actors (Contractors, Engineering, Users) to align them with the project planning.


YOUR PROFIL


  • Have already demonstrated success in C&Q coordination in projects
  • Over 3 years’ experience in C&Q in pharmaceutical area
  • Bilingual French/English (written and spoken)
  • Good experience in managing qualifications projects
  • Good understanding of the injectable manufacturing processes
  • Knowledge in qualifications of HVAC systems, Clean Utilities (Clean Compressed Air, Clean Steam, Purified Water, Water For Injection, ...), autoclaves, analytical systems, CIP/SIP process, filling lines, bulk equipments (chromatography systems, fermentor, …)
  • Planning of activities
  • Good expertise in GMP Practices (V cycle, …)
  • Ability to work under heavy pressure due to the requested flexibility and reactivity of the activities
  • Ability to work in project teams in a multidisciplinary environment and a matricial organization
  • Quality oriented