Sterilization expert

Excelya; Aubagne; Sur place; EUR 35 000 - 55 000; Plein temps

Résumé du poste

A healthcare company in Aubagne is seeking an individual for a role focused on driving innovation in clinical research. The candidate will develop and implement qualification strategies, ensure compliance in sterilization activities, and contribute to a collaborative team environment. Excellent understanding of GMP regulations, along with fluency in French and English, is essential. Join a dynamic team dedicated to redefining excellence in healthcare.

Qualifications

• Proven ability to thrive in collaborative, fast-moving environments.
• Solid understanding of sterilization processes and GMP regulations.
• Experience with deviations (NC) and CAPA management.

Responsabilités

• Develop and implement the qualification strategy.
• Monitor purchase orders and validation report completion.
• Review lots/pallets to be reprocessed.
• Update and maintain the PQ tracking file.
• Identify opportunities for improvement in workflows.
• Analyze reports from service providers.
• Define performance indicators (KPIs) for activities.
• Optimize controls and verify compliance before shipment.

Connaissances

Solid understanding of sterilization processes and GMP regulations

Experience with deviations (NC) and CAPA management

Ability to thrive in collaborative, fast-moving environments

Fluency in French

Fluency in English

Formation

Degree in Quality Assurance

Degree in Pharmacy

Degree in Process Engineering

Description du poste

Social network you want to login/join with:

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Qualify two sterilization processes at Sterigenics (Minerbio site):

• Develop and implement the qualification strategy.
• Monitor purchase orders and validation report completion.

Ensure operational follow-up of product qualifications (PQ):

• Review lots/pallets to be reprocessed.
• Update and maintain the PQ tracking file.

Optimize the management of product qualifications at the Aubagne site:

• Identify opportunities for improvement (workflows, traceability, planning).

Strengthen the understanding and monitoring of Operational Qualification/Product Qualification (OQ/PQ) reports:

• Analyze reports from service providers (Ionisos, Steris, Sterigenics).
• Identify discrepancies, critical points, and areas for improvement.

Define performance indicators (KPIs) for sterilization activities at Aubagne.

Simplify the management of deviations (NC) and CAPAs related to sterilization activities.

• Optimize controls and verify compliance before shipment.

Update associated quality documentation:

• Procedures, work instructions, tracking forms...

Requirements

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—talent matters most to us!)
• Skills: Solid understanding of sterilization processes and GMP regulations; experience with deviations (NC) and CAPA management.
• Education: Degree in Quality Assurance, Pharmacy, Process Engineering, or related field.
• Languages: Fluency in French & English

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.