Role: CSV & QA Specialist
Location: On-site: 4 days per week - Alby Sur Ch ran France
We are looking for an experienced CSV & QA Specialist to support the Digital Factory Program (DFP), a strategic digital transformation initiative aimed at implementing and validating several GxP-critical systems across manufacturing operations.
Key Responsibilities
The Digital Factory Program includes the deployment of:
- K rber PAS-X MES (Manufacturing Execution System) to manage and execute manufacturing operations.
- WMS (Warehouse Management System) to optimize warehouse and inventory management processes.
- AVEVA System Platform for equipment supervision, process integration, and manufacturing recipe management.
- LIMS update
- Empower installation
- Implementation of an Electronic Batch Record (EBR) solution to fully digitalize batch documentation and manufacturing records.
The ultimate objective of the program is to establish a compliant, integrated digital manufacturing ecosystem that enables end-to-end electronic batch record management while ensuring data integrity, traceability, and regulatory compliance.
Candidate Profile
The Ideal Candidate Should Meet The Following Criteria
- More than 8 years of experience in Computerized System Validation (CSV) within regulated environments.
- Demonstrated experience supporting validation projects involving systems such as MES, WMS, or AVEVA System Platform.
- Strong knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11, and Data Integrity requirements.
- Excellent English communication skills, both written and verbal, with the ability to work effectively in an international environment.
- Ability to work independently while collaborating within multidisciplinary project teams.
- Strong organizational, communication, and stakeholder management skills.
- Remote work: 1 day per week.