You have a Master’s degree or an engineering degree. You have a first experience in pharmaceutical industry or medical devices, on projects of equipment qualification (processes, packaging), HVAC classified area, utilities (purified water, water for injection, pure steam, CIP…).
You have a strong appetite for complex projects and problem solving. Your curiosity and your technical culture are recognized in the professional environment but also in the personal environment. You have an easy questioning and constantly seek to improve yourself.
You undertake, carry out projects and commitments. You challenge your methods and ideas to surpass yourself and reach a high level of excellence. In this context, your drivers can be technical, financial or human, you will be valued on your performance and/or that of your team.
This position is open to people with disabilities, adaptations of the position can easily be put in place.
Remuneration will be based on years of experience and specific technical expertise. To support the team, you are able to take the lead on all or part of the following business responsibilities:
Represent the department at project launch and follow-up meetings
Establish, write, update and archive qualification documents according to the procedures in force:
Qualification / Validation Plans (VP)
Qualification protocols / reports (DQ, FAT/SAT, IQ, OQ, PQ)
Traceability matrices (TM)
Data review (DR)
Schedule, organize and conduct DQ/FAT/SAT/IQ/OQ/PQ qualification tests.
Coordinate external service providers involved in initial qualification.
Write and manage deviations according to the system in place during initial qualification.
Ensure the maintenance of the service performance indicators.
Actively participates in the improvement of the qualification process in place in order to improve efficiency and reduce costs You have a good sense of organization, analytical skills and ability to synthesize information
You know how to work independently, as part of a team and communicate across the company
You are able to make proposals to contribute to the improvement of processes
You have knowledge of GMP, ISO and good engineering practices
You have knowledge of unit operations and pharmaceutical and fine chemical installations
You have good writing and interpersonal skills
You have a good command of technical English We are currently handling large-scale projects in many fields such as fine chemicals, medical devices, biotechnology, cosmetics, etc. Our expertise applies to production, logistics, R&D labs, and quality control labs, particularly in complex technical environments: revamping or new units.
Our interventions are based on technical issues related to the following dimensions: