Commissioning and Qualification Engineer, Oral Solid Dosage

Job description

Job Description The Engineering Specialist in our company's Research Labs (Pharm Ops Engineering) leads Commissioning, Qualification, and Validation (CQV) activities and provides engineering support for process equipment and utilities used to manufacture oral solid dosage (OSD) forms. Supporting the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ, the candidate authors and executes CQV protocols (IQ/OQ/PQ) and ensures cGMP compliance and adherence to our company's Quality Manual for new and modified equipment, systems, and critical utilities supporting capital projects and ongoing operations. Candidates should demonstrate effective organizational and communication skills, strong computer proficiency, and the ability to flexibly support both Quality and Facilities/Equipment work are essential, with preferred experience in Kneat (paperless validation), computerized maintenance and calibration management systems (CMMS and CCMS), and the capability to work independently while leading or facilitating tasks. The FLEx Center operates on a two-shift schedule and may require coverage beyond standard business hours. Candidates may be required to work extended 1st shift...