Fermentation Process Engineer

Union Agener•Augusta, GA

4d•Onsite

About The Position

This role provides day-to-day support for manufacturing operations, including resolving manufacturing deviations and troubleshooting process issues. The engineer will also provide automation technical support for the area's control system platform and drive safety, quality, efficiency, and cost reduction projects in the upstream purification processing area. Key responsibilities include participating in safety-related activities, taking responsibility for the safe design and operation of equipment, maintaining the qualified state of systems, and interacting with Regulatory Agencies during audits. The position requires technical ownership of equipment and processes, establishing and monitoring control systems for optimization, leading troubleshooting efforts, and utilizing formal problem-solving techniques like Root Cause Analysis. Effective communication with manufacturing teams, customers, engineering specialists, and crafts personnel is essential. The role also involves evaluating activities for impact on the qualified state of equipment/processes, managing system/component classification and maintenance strategies, implementing CAPA corrections, participating in Periodic Reviews, and leading or participating in qualification activities, including commissioning.

Requirements

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.).
Understand and apply pharmaceutical cGMPs to all aspects of work processes.
Work effectively with other plant functions, including Quality Assurance, Quality Control, Engineering, Validation, Metrology, and Logistics.
Strong written and oral communication skills. Communicate effectively with all levels of the organization, from plant management to operations specialists.
Excellent organizational, project, and time management skills.
Able to handle change productively and handle other tasks as assigned.
Experience with Data Historian such as AspenTech Process Explorer or similar system.

Nice To Haves

Master’s degree in Chemical Engineering, Biochemical Engineering or related field.

Responsibilities

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.