Process Engineer I

Role: Process Engineer I or II supporting GMP manufacturing operations in the biopharma sector, focusing on equipment validation, maintenance, and compliance. Responsibilities: ensure proper design and qualification of new equipment, perform preventative maintenance, calibrations, and modifications to maintain validated state; investigate deviations and implement corrective actions; support audit and inspection activities as SME; monitor equipment performance and evaluate new technologies. Requirements: B.S. in Chemical, Electrical, Mechanical Engineering or related field; Process Engineer I requires <2 years (or 4 years equivalent) experience, while Process Engineer II requires >2 years (or 6 years equivalent); strong communication skills; experience in pharmaceutical or biotech GMP environment; knowledge of FDA regulations and GMP systems. HighValue: GMP manufacturing support in biopharma, equipment validation and maintenance, audit readiness, highly regulated environment, potential support for bioreactors, filtration, chromatography, and filling equipment, with a focus on compliance and quality assurance.