Cleaning Validation & CSV Specialist – Pharmaceutical Manufacturing

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

Strasbourg, France | Contract | 5 Days On-Site

Please note: This position requires a full-time on-site presence in Strasbourg, five days per week. Previous professional experience working within a pharmaceutical manufacturing environment is essential. If you cannot commit to five days per week on-site or do not have previous pharmaceutical industry experience, please do not apply.

We are currently recruiting for an experienced Cleaning Validation & CSV Specialist to support a major pharmaceutical manufacturing expansion project in Strasbourg, France.

The project involves the installation, commissioning and qualification of new pharmaceutical manufacturing equipment and production areas ahead of operational and GMP readiness.

Working from the user/operations side, you will be responsible for preparing and maintaining documentation associated with new equipment from a Cleaning perspective, while ensuring relevant Computerized System Validation (CSV) requirements are appropriately addressed.

Key Responsibilities

• 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.

Experience Required

• Previous experience within 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.
• Experience preparing and reviewing GMP documentation, SOPs and operational procedures.
• Experience supporting the introduction or validation of new manufacturing equipment.
• Strong documentation and stakeholder-management skills.
• French language capability is required due to the site-based nature of the project.
• Must be available to work on-site in Strasbourg five days per week.

This is an opportunity to support a significant pharmaceutical expansion programme and take ownership of critical Cleaning, CSV and operational documentation as new manufacturing equipment moves towards GMP operation.