Responsibilities:

· Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports

· Development of 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)

· Development of thermal validation study protocols

· Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested)

· Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)

· Coordination of junior resources for qualification testing execution and use of test instruments

· Development of risk based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)

· Development of calibration and maintenance plans and related instructions

· Development of standard operating procedures

· Advanced knowledge of EU and US GMP

Requirements:

· Technical Degree (Engineering, Chemistry, Biotechnology, Informatics, Physics, Mathematics, etc.)

· +5 experience in the Equipment and Installation Qualification of drug manufacturing area (Life Science / Pharmaceutical Sector)

· Integrity, strong ethics, analytical skills and attention to details