Cleaning & CSV Documentation Specialist

Meet Life Sciences; Strasbourg; Sur place; EUR 83 000 - 165 000; Plein temps

Résumé du poste

Meet Life Sciences is seeking a Freelance Cleaning & CSV Documentation Specialist for a pharmaceutical manufacturing project in Strasbourg. You will prepare documentation for new equipment from the Cleaning perspective, ensure CSV compliance, and help develop the Operational Handbook.

The role requires hands-on experience with Cleaning, CSV, and GMP in pharma manufacturing, with onsite work in Strasbourg on a 5-day-per-week basis.

Qualifications

• Strong cross-functional communication and stakeholder management skills.
• Experience with GMP environments and Cleaning Validation.
• Experience with Computerized System Validation (CSV) requirements.
• Experience supporting new equipment projects within pharmaceutical manufacturing.
• Available to work onsite 5 days per week in Strasbourg.

Responsabilités

• Prepare user documentation related to new manufacturing equipment from the Cleaning department perspective.
• Ensure documentation meets relevant Computerized System Validation (CSV) requirements.
• Develop and maintain the Operational Handbook.
• Support documentation activities associated with the introduction of new equipment.
• Work cross-functionally with Cleaning, Validation, Quality and wider project stakeholders.
• Ensure documentation is accurate, compliant and maintained throughout the project.

Connaissances

Cross-functional communication

Stakeholder management

GMP knowledge

CSV knowledge

Cleaning validation

Description du poste

Freelance Cleaning & CSV Documentation Specialist - Pharmaceutical Manufacturing

I'm currently supporting a pharmaceutical organisation looking for an experienced Cleaning & CSV Documentation Specialist to support a new equipment project at their manufacturing site in Strasbourg.

The consultant will represent the user side from a Cleaning perspective, taking responsibility for preparing the required documentation for new equipment, ensuring CSV requirements are met and supporting the development and maintenance of the Operational Handbook.

Key Responsibilities:

• Prepare user documentation related to new manufacturing equipment from the Cleaning department perspective
• Ensure documentation meets relevant Computerized System Validation (CSV) requirements
• Develop and maintain the Operational Handbook
• Support documentation activities associated with the introduction of new equipment
• Work cross-functionally with Cleaning, Validation, Quality and wider project stakeholders
• Ensure documentation is accurate, compliant and maintained throughout the project

Key Requirements:

• Strong experience within pharmaceutical/biopharmaceutical manufacturing
• Previous Cleaning/Cleaning Validation experience within a GMP environment
• Experience with Computerized System Validation (CSV) requirements
• Experience supporting new equipment projects within pharmaceutical manufacturing
• Strong cross-functional communication and stakeholder management skills
• Available to work 5 days per week onsite in Strasbourg

If you have relevant Cleaning, CSV and pharmaceutical manufacturing experience and are available for a new freelance project, please get in touch!