Validation engineer

Company:United Pharma Technologies
Location:Rocky Mount, NC
EngineeringHealthcare & Community
Job Category:
Engineering, Healthcare & Community
Full timeContract
Employment Type:Full time, Contract
Salary:$70,000 - $80,000

Job Description:

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 Decommissioning protocols • 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.


Company Info

Address:908 Oaktree Ave
Location:South Plainfeild, NJ
Phone: 908-3315987