The Production Engineer will be a Operations technical expert and responsible for reviewing documentation for Operations to implement projects for the manufacture of APIs, bulk intermediates, and other products from development through piloting and/or commercial production.

• 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.
• Additional job duties as assigned.

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

• Knowledge of and/or direct experience in a cGMP environment is preferred
• General knowledge of chemical operations equipment and manufacturing operations

• BS in Chemical Engineering or similar field, plus 1 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience

PI288189598