Raynham MA
Job Description:
>> Writing and execution of validation protocols and reports (i.e. IQ OQ PQ etc.)
>> Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation.
>> Updating procedures, manufacturing specifications, bills, routes and travelers for product process changes in the PLM system.
>> Working with OEM equipment manufacturers and distributors to develop user requirements.
>> Work on new asset commissioning.
>> Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals.
>> Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects.
>> Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements:
>> Manufacturing engineer