Project Manager - Qualification Validation (M/F)

MEENT is a leading company in the life sciences field, offering solid expertise in engineering consulting and clinical research. Our commitment to innovation and quality allows us to provide tailored solutions in response to the complex challenges of our clients in the Health sector.

The position:

Missions:

• Participation in design and development work for the selection, installation, and validation of packaging equipment
• Risk analysis, identification of critical parameters, and validation of changes to packaging equipment and processes, including packaging materials
• Development of validation strategies and drafting of qualification/Validation documents (PV, RA, FAT/SAT, IQ/OQ/PQ) in compliance with standards and requirements (BPF, GMP...)
• Implementation and management of cross-functional teams (production, maintenance, supplier, logistics...) in working groups to coordinate the execution of qualification test protocols
• Updating procedures and systems within the scope of the activities for which you are responsible
• Participation in the lifecycle management of products, processes, and equipment, including problem-solving
• Technical support in the event of deviations or in response to Quality improvement notifications related to equipment and packaging materials

Profile sought:

Experiences:

• Education level Bac+4/5
• Minimum of 4 years of real experience in system and equipment validation, ideally in the pharmaceutical industry or in a demanding environment such as the Pharmaceutical industry.
• Experience related to the packaging of solid oral dosage forms (blisters, sachets, glass vials, carton packaging or cases)

Professional skills:

• Knowledge of control and validation/qualification requirements as well as risk analysis and problem-solving tools
• Ideally, good knowledge of packaging equipment

Additional skills and requirements:

• Analytical and diagnostic skills.
• Methodical and rigorous.
• Ability to work within a team of specialists and generalists.
• Proficiency in spoken/written English.
• Interest in collaborative work, interpersonal skills, and the ability to propose solutions.
• Autonomy