Process Engineer
$90,000–$100,000 year
On-site · Augusta, Georgia, United States
Job Summary
Process Engineer to support day-to-day operations in a manufacturing setting, focusing on deviation resolution, automation support for control systems, and driving safety, quality, efficiency, and cost-reduction projects in upstream purification processes. Responsibilities include leading troubleshooting efforts, applying RCA tools, maintaining qualified state of equipment and systems, interacting with regulatory agencies during audits, owning equipment/process technical aspects, establishing control-system monitoring, participating in CAPAs and qualification activities, and contributing to capital project scoping and commissioning of new equipment. Requires a BA/BS in Chemical/Biochemical Engineering or related field, 1-5 years in FDA-regulated manufacturing with upstream protein purification, familiarity with cGMPs and with production-scale unit operations and automation (PLC/DCS). Strong communication and cross-functional collaboration skills, analytical problem-solving abilities, and the ability to operate in a manufacturing environment are essential.
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.)
- 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
- Excellent organizational, project, and time management skills
- Must be able to perform and review work in a manufacturing plant environment
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