Sr. Production Engineer

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.
• Aid 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.
• Participate in troubleshooting, investigating process problems and deviations, and prepare appropriate reports on findings.
• Participate in HAZOPs and provide guidance on corrective actions when needed.
• Complete CAPAs and audit action items as assigned.
• Train Operators or Technicians on equipment and process operations as needed to ensure safe and efficient manufacturing.

Qualifications/Skills

• 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.

Education, Experience & Licensing Requirements

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