Production Engineer

Roles & Responsibilities Writing batch records and cleaning records for commercial products or simple revisions, campaign reports, as needed to support production operations. Initiate SOPs and investigations/deviation reports/CAPAs for production operations and commercial products. Reviewing and approving documentation (batch records, cleaning records, supplements, etc.) for Operations as the area technical expert. Troubleshoot equipment and coordinate with maintenance to monitor equipment for efficiency improvement. Assist Process Engineers and Chemical Development teams when new processes are transferred into the area workcenter. Work with Validation Engineering and Maintenance departments on developing and maintaining IQ, OQ and PQ documents and protocols. Ownership of equipment and facility change controls in their assigned area workcenter. Generate product setups and cleaning memos as needed. Troubleshooting, investigating process problems and deviations, and preparing appropriate reports on findings. Participating in HAZOPs and providing guidance on corrective actions when needed. Completing CAPAs and audit action items as assigned. Train Operators or Technicians on equipment and process operations as needed to ensure safe and efficient manufacturing. Requirements B.S. degree in Chemical Engineering or related field. At least 1-3 years post-grad experience as a Production Engineer or Equipment Engineer, specifically in a pharmaceutical manufacturing environment. Experience with GMP/cGMP standards Must have experience these types of equipment: APIs, reactors, filter dryers, pumps, but also just more unit operators (reactions, distillations, crystallizations, filtrations, vacuum etc.). #J-18808-Ljbffr