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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