Your Responsibilities
- Coordinate qualification and validation activities for cleaning equipment (e.g., washers, COP stations).
- Manage change controls and deviations using the Viva system (internal training provided).
- Support the qualification of new equipment and validation activities by coordinating with production and support teams (e.g., ensuring availability of materials and personnel).
- Collaborate with a Process Engineer on Washer and COP/SOP-related activities.
- Participate in the review of validation protocols, test sheets, and reports.
- Conduct regular on-site follow-ups and coordinate with production and automation teams.
- Oversee technical layout aspects (e.g., moving conduits, ensuring furniture compliance, etc.).
- Provide support during layout activities and machine qualification for the summer shutdown.
Documentation Responsibilities
- Write and manage operational procedures (SOPs).
- Draft and follow up on change controls and deviations.
- Write URS (User Requirement Specifications) and Design Verification (DV) documents.
- Review and approve qualification documentation as needed.
Your Profile
- 3 to 7 years of experience in qualification/validation or production within the pharmaceutical industry, ideally in sterile manufacturing.
- Strong knowledge of Good Manufacturing Practices (GMP).
- Proven coordination skills and ability to track qualification activities.
- Experience in deviation and change control management.
- Basic understanding of CSV qualification and automation processes.
- Experience with cleaning systems (CIP/SIP) and automation tools (e.g., AVEVA) is a plus.
- Familiarity with layout planning, equipment installation, and project management tools (e.g., MS Project, Excel).
- Project management skills using MS Project or Excel.
- Fluent in French, with strong English writing skills.
Our offer:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV,
[email protected]
