Job Location:Remote - Japan
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 being a part of 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 a new Commissioning & Qualification Engineer Consultant to join our CQV Team in Japan. Working in a consulting reality as PQE Group will give you the chance to work on projects for the most important national and international pharmaceutical companies. This opportunity will allow you to travel in Japan to visit our clients’ sites and quickly increase your professional experience thanks to the constant support of a multicultural team of expert consultants and continuous on the job training.
- 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
Responsibilities include, but are not limited, to the followings:
- Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics)
- Minimum of 2-3 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: Fluent (mandatory)
- Integrity, strong ethics, analytical skills and attention to details
If interested, please send your resume clicking the "APPLY NOW" button on this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order 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.