C&Q ENGINEER PHARMA H-F
Il y a 2 heures
Wavre, Wallonia, Belgique
EFOR
Temps plein
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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
- 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