C&Q ENGINEER PHARMA H-F

EFOR; Wallonië; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

EFOR Belgium seeks an experienced C&Q specialist for vaccine manufacturing projects, ensuring proper execution of C&Q methodology and cGMP throughout the program.

You will coordinate commissioning and qualifications, review protocols, approve reports, and advise on deviations while working with HVAC, Clean Utilities, autoclaves, CIP/SIP, filling lines, and bulk equipment to ensure GMP compliance.

Qualifications

• Over 3 years’ experience in C&Q in pharmaceutical area.
• 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 equipment(s).
• Planning of activities and schedules for qualification campaigns.
• Strong GMP knowledge and ability to work under pressure and meet timelines.
• Experience coordinating contractors, engineering teams and users within projects.

Responsabilités

• Follow and coordinate the commissioning and qualifications during a project.
• Review and ensure the compliance of the qualification protocols, review the qualification data and approve the reports for conformance.
• Advise the various actors in case of issues or deviations and guide resolution.

Connaissances

C&Q in pharma

Project management

GMP practices

Multidisciplinary teamwork

French/English bilingual

Description du poste

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

• Over 3 years’ experience in C&Q in pharmaceutical area, good experience in managing qualifications projects
• 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
• Bilingual French/English (written and spoken)