Commissioning & Qualification Consultant – Pharma Sector

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas . Following a new opportunity, we are looking for many Commissioning & Qualification Engineer Consultant to join our Commissioning & Qualification Team in Italy in our offices based in Milan, Florence, Ascoli Piceno, Mirandola, Fidenza and Rome. You will be responsible for: · 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 About you: · Minimum of 2 years of experience in Pharmaceutical Sector · Degree in Pharmaceutical/Industrial related subject · 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) · Full availability to travel domestically and abroad (at least 50%) · Integrity, strong ethics, analytical skills and attention to details · Pharmaceutical Engineering background will be considered a plus · Strong Analytical and Organizational Skills · Team management skills · Great communication skills and ability to communicate with diverse Stakeholders Locations : Milan, Florence, Ascoli Piceno, Mirandola, Fidenza and Rome. As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us. J-18808-Ljbffr