Strasbourg On-Site: Cleaning Validation & CSV Specialist

Meet Life Sciences; Strasbourg; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Meet Life Sciences in Strasbourg, France is seeking an experienced Cleaning Validation & CSV Specialist for a major pharmaceutical manufacturing expansion. The role requires five days on-site per week, with responsibility for preparing and maintaining cleaning-related and CSV documentation for new equipment and processes.

You will work closely with Cleaning, Validation, Engineering, Quality and Manufacturing teams to ensure GMP readiness and compliance with GMP, GAMP 5, and SOPs throughout

Qualifications

• Previous experience in a pharmaceutical manufacturing environment is essential.
• Strong experience with Cleaning Validation and/or cleaning documentation.
• Practical knowledge of Computerized System Validation (CSV) within a GxP environment.
• Understanding of GAMP 5 principles.

Responsabilités

• Prepare and maintain user-side documentation associated with new pharmaceutical manufacturing equipment.
• Support documentation activities from the Cleaning and Cleaning Validation perspective.
• Ensure relevant equipment and systems meet applicable CSV requirements.
• Support documentation in accordance with GMP and GAMP 5 principles.
• Develop and maintain the Operational Handbook for new equipment and processes.
• Prepare, review and update relevant SOPs, procedures and operational documentation.
• Work closely with Cleaning, Validation, Engineering, Quality and Manufacturing stakeholders.
• Support documentation readiness as new equipment progresses through commissioning, qualification and operational handover.
• Ensure documentation is complete, compliant and ready for use within the GMP manufacturing environment.

Connaissances

Cleaning Validation

CSV

Documentation

Stakeholder management

GMP

GAMP 5

SOP development

French language

Description du poste

Meet Life Sciences in Strasbourg, France is seeking an experienced Cleaning Validation & CSV Specialist for a major pharmaceutical manufacturing expansion. The role requires five days on-site per week, with responsibility for preparing and maintaining cleaning-related and CSV documentation for new equipment and processes.

You will work closely with Cleaning, Validation, Engineering, Quality and Manufacturing teams to ensure GMP readiness and compliance with GMP, GAMP 5, and SOPs throughout