Union Agener, Inc. · 10 hours ago
Process Engineer
Augusta, GA
Full-time
Onsite
Entry, Mid Level
1+ years expUnion Agener is focused on manufacturing operations and is seeking a Process Engineer to provide day-to-day support in resolving manufacturing deviations and troubleshooting process issues. The role involves driving safety, quality, efficiency, and cost reduction projects, while also providing technical ownership of equipment and processes in the area of responsibility.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
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
Preferred
Master's degree in Chemical Engineering, Biochemical Engineering or related field
Benefits
Competitive Salary
Competitive Benefits Package and Employee Assistance Program
401(k) Plan + Company Match
Vacation + End of Year Vacation (Company Sponsored)
Growth Opportunities to expand your career
Company
Union Agener, Inc.
Union Agener is an animal pharmaceutical company and we fall under the parent company of Uniao Quimica, located in Brazil.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase