Which organization will you join as a CSV Technician / Engineer (M/F)?

We are looking, on behalf of one of our clients-a major player in the pharmaceutical industry-for a CSV Technician / Engineer (M/F). The position will be based in the Auvergne-Rhône-Alpes region for a duration of 4 to 6 months, renewable.

Assignment context

Within one of our pharmaceutical clients operating in a highly regulated environment, the CSV Technician / Engineer (M/F) will be involved in a project for the qualification of laboratory equipment and associated computerized systems.

The objective is to ensure regulatory compliance (GMP) and equipment reliability through the execution of qualification activities (IQ, OQ, PQ).

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

Main mission

In collaboration with Quality, Validation, Production teams, and suppliers, you will be responsible for qualifying laboratory equipment and associated systems in compliance with regulatory requirements and site quality standards.

Main activities

Perform risk assessments and contribute to the qualification strategy
Draft and execute qualification protocols (IQ, OQ, PQ)
Analyze results and manage deviations (deviations, CAPA)
Write qualification reports
Coordinate with internal teams and suppliers
Participate in FAT/SAT when required
Contribute to computerized system validation (CSV)
Update quality documentation
Support regulatory compliance and audits

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

Education & experience

Degree ranging from Associate's to Master's (pharmaceutical sciences, biotechnology, quality, engineering, or equivalent)
Minimum 2 to 5 years of experience in CQV / validation within the pharmaceutical industry
Experience in CSV (Computer System Validation)
Experience in laboratory equipment qualification (QC)
Knowledge of GMP environments (mandatory)
Professional English (preferred)

Technical skills

Knowledge of computerized systems validation activities (IQ, OQ, PQ)
Strong understanding of GxP requirements and Data Integrity (ALCOA+)
Familiarity with laboratory computerized systems (CDS, LIMS)
Experience in deviation management, CAPA, and change control
Ability to manage multiple systems and priorities

Personal qualities

Rigorous and detail-oriented
Strong analytical and synthesis skills
Autonomous and proactive
Good interpersonal skills and ability to work cross-functionally
Ability to manage priorities in a demanding environment

Interested in this position? Send me your application!

EP2C Energy is committed to diversity and inclusion. We encourage applications from individuals recognized as disabled workers.

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 the ambition of making a positive contribution to the environment.

Our company is committed to continuous improvement through its Quality Management System (QMS) and its Health, Safety, and Environment Management System (HSE MS).

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