Validation Coordinator Engineer (M/F) - Belgium
Validation Coordinator Engineer (M/F)
With more than 350 consultants, CVO-EUROPE provides expertise in every activity that may affect patient health, product quality or data integrity.
CVO-EUROPE is an international group with business divisions in France, Belgium, Switzerland, and the USA.
The aim is to provide support to a project team for commissioning & qualification coordination (FAT/SAT/IQ/OQ).
Tasks and responsibilities :
• In the context of investments projects (new or upgrades) in vaccines production, ensure proper execution of the validation 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
• Have 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.
• Minimum 5 years practical experience in C&Q coordination in projects
• Knowledge in qualifications of HVAC systems, Clean Utilities, autoclaves, analytical systems, CIP/SIP process, filling lines, bulk equipments
• Experience in the Pharmaceutical industry
• Bilingual French and English
• Knowledge in SAP and MS Office
• An international Leader Company in the Engineering, Validation and Quality sector, which offers you interesting project.
• A strong corporate culture ensuring a personal and professional blooming and self-fulfillment.
• Overall trainings and a personal career management.
• A good salary package with a lot of extra legal advantages.