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Union Agener1 day ago

Fermentation Process Engineer

On-site · Augusta, Georgia, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Provide day-to-day support area manufacturing operations, including resolution of manufacturing deviations and troubleshooting process issues. Provide automation technical support to area for automation control system platform. Drive safety, quality, efficiency, and cost reduction projects in upstream purification processing area. Actively participate in safety-related activities (audits, hazard reviews, etc.) to drive ongoing safety improvement. Take overall responsibility for the safe design and safe operation of the equipment within the area. Maintain the qualified state of systems supported. Interact with Regulatory Agencies during audits and assessments. Provide technical ownership of equipment and processes in area of responsibility. Establish & monitor/trend control systems as tool for verifying and optimizing equipment performance. Lead troubleshooting efforts to resolve more difficult process and operational problems. Utilize formal problem solving techniques, including Root Cause Analysis, to resolve equipment issues. Communicate effectively with others, especially manufacturing team members, customers, engineering specialists, and crafts personnel. Evaluate all activities for impact on qualified state of equipment/processes and utilize appropriate tools/processes as necessary (change control, hold, etc.). Responsible for system/component classification and maintenance strategy for equipment. Implement corrections, corrective actions, and countermeasures arising from CAPAs. Participate in Periodic Reviews for systems. Lead or participate in qualification activities (including commissioning activities of new equipment or areas). Develop scope for capital projects targeted at both short and longer term needs.

Required Qualifications

  • BA/BS degree in Chemical Engineering, Biochemical Engineering or related field
  • 1-5 years experience in FDA regulated manufacturing operations, preferably with upstream protein purification
  • Understanding and experience with pharmaceutical cGMPs
  • Understanding and experience with production scale unit operations such as Fermentors Centrifuge Hemogenizer, Formulation milling, refold, ultra-filtration, precipitation, and chromatography
  • Understanding and experience with automated processes. Familiarity with PLC Control Systems and/or DCS (i.e. PRoVOX, Wonderware, etc.)
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Union Agener

Fermentation Process Engineer

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