- J&J Family of Companies (Danvers, MA)
- …meet business objectives. + Implement robust processes for hardware verification, validation , and lifecycle management. + Partner with advanced technology teams to ... _Required:_ + Bachelor's degree in Electrical Engineering, Biomedical Engineering, or Computer Engineering. + 12+ years of experience in hardware/system engineering,… more
- Integra LifeSciences (Braintree, MA)
- …issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of refrigerant usage and system ... environmental conditions (cold rooms, mechanical spaces, etc.). + Basic computer skills and experience with CMMS (Computerized Maintenance Management Systems).… more
- Sumitomo Pharma (Boston, MA)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Catalent Pharma Solutions (Chelsea, MA)
- …experience, preferably in cGMP biopharmaceutical, pharmaceutical, medical device, food, or other FDA regulated industry + Must have basic computer skills - ... consumer, and Catalent employee.** **The Role:** + Provide support for validation , calibration, and preventative maintenance of all Good Manufacturing Practices… more
- Sumitomo Pharma (Boston, MA)
- …undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. + Work closely with ... to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge...communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America… more
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