Process & Validation Engineer (100% Travel)

Bachelor’s degree in Engineering, Bio/Pharma Science, or a related technical field. 4-7 years of related engineering and/or technical experience. Experience with cGMP Manufacturing within an FDA-regulated manufacturing company. Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company. Knowledge of FDA regulations and guidance or applicable regulatory standards and practices. Proficient with MS Office suite, MS Project, Visio, and related electronic formats. Knowledge of laboratory and manufacturing systems such as LIMS, MES. Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer. Experience with Fillers, Wave Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and Flow Cytometers. Excellent computer, verbal, and written communication skills. Innovative problem-solving skills. Accountable and responsible individual. Willingness to travel to various clients when needed.

Assist with requirements specifications, design, development, commissioning, and qualification of process equipment or systems. Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE). Assist with risk assessments, feasibility reviews, and testing of process materials. Assist with requirements specifications, design & development of process parameters, and commissioning/validation of manufacturing processes. Provide technical support for the product/process lifecycle and related activities. Support client requirements for process or engineering projects at vendors or third-party contract companies. Provide support for improvement projects regarding processes and systems. Support or provide risk assessment and mitigation activities. Provide technical support for scale-up activities from development to manufacturing. Analyze and recommend improved technology to increase quality and efficiency. Provide technical analysis and support for new or improved process systems. Facilitate and schedule meetings with subject matter experts. Ensure compliance with cGMP, regulatory, and industry standards.