PQE Group is hiring CDD

Commissioning & Qualification Consultant

– Pharma Sector – FRENCH Speaker

À propos de l’offre d’emploi

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 1500 employees, 45+ nationalities and 28 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world.

Due to a constant growth, PQE is looking for new CQV Consultants – FRENCH Speakers to join our Commissioning & Qualification Team.

Responsibilities:

• Management of qualification and test plans according to specific technical requirements, requirements-testing traceability matrixes and design qualification and summary reports
• Drafting, verification and execution of protocols and qualification test (FAT, SAT, IQ, OQ, PQ)
• Installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)
• Drafting of thermal validation study protocols
• Development of project validation master plans for new sites implementation including detailed Gantt charts with resources workload evaluation (advanced knowledge of Microsoft Project requested)
• Risk-based process analysis according to international methodologies (e.g.: FMEA, HACCP)
• Creation of calibration and maintenance plans and related instructions
• Standardization of operating procedures

Requirements:

• Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics)
• Minimum of 1-2 years of experience in Pharmaceutical Sector
• Advanced knowledge of FAT, SAT, IQ, OQ, PQ procedures and documentation
• Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
• English and French: Fluent (mandatory)

Location: Home office with Full availability to travel domestically and abroad (at least 80% of the time)

Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.