Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Mission

As part of the Technical Services – Qualification, Validation & Metrology department, you will be responsible for performing and supporting activities related to equipment qualification, validation, and metrology within a GMP-regulated biopharmaceutical environment.
You will ensure that equipment and utilities used in manufacturing and laboratory areas meet all regulatory, quality, and performance requirements, while contributing to continuous improvement and reliability initiatives across the site.

Key Responsibilities

Perform and document equipment qualification (IQ/OQ/PQ) and requalification activities according to internal procedures and GMP standards.

Support the introduction of new equipment: preparation, execution, and follow-up of qualification and calibration activities.

Plan and complete calibration activities to guarantee full metrological traceability of instruments used in production and QC.

Review and approve calibration certificates from service providers and ensure timely data entry in SAP / CMMS.

Diagnose technical deviations, analyze root causes, and define corrective/preventive actions.

Contribute to continuous improvement projects: process optimization, documentation simplification, standardization, and automation.

Participate in equipment FAT/SAT, change controls, and deviation investigations.

Ensure compliance with GMP and safety statutes in all daily activities.

Collaborate with Production, Maintenance, QA, QC, and Engineering to ensure timely project execution.

Maintain a high level of technical expertise and support internal training when required.

Profile

Technical Bachelor’s degree (Electromechanics, Automation, Instrumentation, Biotechnology, or Metrology) or equivalent experience.

3–5 years of validated experience in a GMP-regulated environment (pharma, biotech, or similar), ideally in CQV and/or Metrology.

Strong technical understanding of:

Production and laboratory equipment (bioreactors, balances, incubators, freezers, etc.)

Instrumentation (pressure, temperature, humidity, flow, CO₂, etc.)

Proficient in SAP PM / CMMS, MS Office, and Environmental Monitoring Systems (FMS).

Knowledge of qualification and calibration documentation in a GMP framework (protocols, reports, certificates).

Analytical approach, problem-solving ability, autonomy, and attention to detail.

Good communication skills in English (French is an asset).

Electrical authorization (BA4/BA5) preferred.

Why Join Us

Be part of an extraordinary biopharmaceutical site producing clinical and commercial products under strict GMP regulations.

Work in a dynamic team where technical excellence, compliance, and continuous improvement drive our success.

Grow your expertise in a multidisciplinary environment that values collaboration, innovation, and quality.