Production Engineer

• 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.).