C&Q Projects Coordinator Engineer (M-F)
Belgique
CVO/BE/ING/1015
To support our development, we are looking for :
C&Q Projects Coordinator Engineer (M-F)
Permanent contract
Responsibilities
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.
• 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.
Qualifications/Skills
• Have already demonstrated success in C&Q coordination in projects
• Over 5 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
OUR OFFER
• 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 lot of extra legal advantages.
Interested ? Don’t hesited to send your CV via our website
• Over 5 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
OUR OFFER
• 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 lot of extra legal advantages.
Interested ? Don’t hesited to send your CV via our website
publication date : 01/03/2019