C&Q Projects Coordinator Engineer (M-F)
Belgique
CVO/BE/ING/1015
EFOR-CVO is EFOR Group’s Life Sciences brand, a result of two major consulting actors brought together at the end of 2020: Efor Healthcare and CVO-EUROPE. We have decided to join forces to assist medical device manufacturers and pharmaceutical, cosmetic and biotechnology industries, in order to become the leader in the Life Sciences consulting sector.
Our group of over 1300 experts seeks to become the market leader by providing a unique approach to consulting across the full product development cycle of our clients’ business and products and who are subjected to stringent regulatory demands.
Together with the same international aspiration, we gather unique, committed and passionate women and men, working towards our clients’ performance.
Join us now !
Our group of over 1300 experts seeks to become the market leader by providing a unique approach to consulting across the full product development cycle of our clients’ business and products and who are subjected to stringent regulatory demands.
Together with the same international aspiration, we gather unique, committed and passionate women and men, working towards our clients’ performance.
Join us now !
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 : 29/11/2021