Process Engineer I

Role: Support technical activities for Medical Device manufacturing in the Solutions Process Development Pilot Laboratory, focusing on validation, equipment maintenance, and documentation. Responsibilities: perform validation activities, support compounding, filling, packaging, and labeling of sterile/non-sterile products; manage environmental monitoring and water systems; oversee maintenance and calibration of utilities and equipment; manage inventory and supply chain for raw materials; create and review documentation, SOPs, and maintenance instructions; ensure GMP compliance and maintain a safe work environment. Requirements: Bachelor’s degree (0-3 years experience) or MS (0-2 years); experience in GMP laboratories or manufacturing environments; knowledge of GMPs, documentation practices, and quality systems; strong organizational, communication, and teamwork skills. HighValue: Medical Device manufacturing, sterile/non-sterile processing, validation, GMP compliance, utility and equipment management, documentation control. WorkSetup: unspecified, but involves laboratory and manufacturing settings with routine maintenance and validation activities.