Job Description: Primary tasks include Building out and execution of the R & D Instrument Periodic Review Plan. Candidate will need to have knowledge of qualification in an FDA regulated environment. Project management skills are a plus. Candidate will be giving weekly status reports to the Manager, R & D Systems. Candidate will also be interacting with existing team and engaging them in activities as needed. Review experience of existing systems with an emphasis in monitoring and maintaining GMP status is a big plus. Knowledge of ER/ES Data Integrity is important as well. All levels of Instruments and equipment will need to be addressed from Computerized analytical instrumentation to pH meters used in GMP activities. There are approximately 300 instruments and equipment that will need to be addressed.General Tasks: Small project execution. Troubleshooting/commissioning/validation. Documentation generation (specifications, protocols, etc) Support of maintenance of operation equipment. General requirements: BS or MS degree in engineering or other scientific background. Should be familiar with biopharmaceutical equipment and must have good GMP knowledge. Work well independently as well as in a team. Years of Experience 3-5.Position Comments visible to MSP and Supplier: Please see the body of the Job description for further requirements for the position.
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering