In what environment will you work as a CSV Engineer (M/F)?

We are currently looking on behalf of one of our clients, a leading pharmaceutical company, for a CSV Engineer (M/F).

Mission context

As part of computerized systems implementation and validation projects, the CSV Engineer (M/F) will ensure regulatory compliance of systems used in GMP environments.

CSV Engineer (M/F): What will be your roles and responsibilities?

Main mission

In collaboration with Quality, IT and operational teams, you will manage computerized systems validation activities in compliance with regulatory requirements and site quality standards.

Main activities

• Perform risk assessments
• Write validation documentation (VMP, URS, IQ/OQ/PQ)
• Execute validation testing activities
• Manage deviations and CAPA
• Participate in change control activities
• Support audits and inspections
• Contribute to Data Integrity compliance
• Coordinate with IT teams and suppliers
• Update quality documentation

What profile and skills are required for this CSV Engineer (M/F) position?

Education & experience

• Master's degree in industrial IT, quality or equivalent
• Minimum 3 years of experience in CSV within pharmaceutical environments
• Knowledge of GMP and GAMP5 requirements
• Experience with LIMS, MES, SCADA or CDS systems appreciated
• Professional English appreciated

Technical skills

• Strong knowledge of CSV activities
• Understanding of Annex 11 and 21 CFR Part 11 requirements
• Experience with deviations and change control
• Knowledge of Data Integrity ALCOA+ principles
• Ability to work in regulated environments

Soft skills

• Rigor and organization
• Analytical mindset
• Autonomy
• Good cross-functional communication skills
• Ability to manage multiple priorities

Interested in this opportunity? Send us your application!

EP2C Energy is committed to diversity and inclusion. We encourage applications from individuals with disabilities.

As part of our Quality, Health, Safety and Environment (QHSE) policy, we place great importance on compliance with QHSE rules to ensure a safe working environment for our employees, with a strong commitment to environmental responsibility.

Our company is engaged in a continuous improvement approach through its Quality Management System (QMS) and Health, Safety and Environment Management System (HSE-MS).

By joining our teams, you will follow HSE procedures and best practices while contributing to the continuous improvement of our processes.