Engineer II

Engineer II to lead projects in a GMP manufacturing environment, overseeing engineering activities for equipment, utilities, facilities, systems, and processes. Responsibilities include authoring specifications and supporting documentation (URS, RA, FS) for new processes and equipment; scoping, executing, and managing engineering projects; leading equipment commissioning tests; conducting validation/qualification studies for utility systems, equipment, cleaning, processes, and computer systems; managing multiple qualification activities and timelines; leading cross-functional team meetings and documenting actions; forecasting project requirements; programming and operating analytical instruments for controlled temperature/humidity qualifications; collaborating with process experts to resolve technical challenges; recommending process improvements; drafting change controls and deviations; authoring SOP updates related to CAPA; maintaining compliance with cGMP and safety protocols; and utilizing standard software tools. Requires a Bachelor’s degree and 2-5 years GMP manufacturing experience, with expertise in cleaning validation, aseptic filling qualification, component preparation qualification, and packaging qualification, plus strong technical writing and FDA regulatory familiarity.