Process Engineer

 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.

Minimum Qualification (Education, Experience and/or Training, Required Certifications):Education:

 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.

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

 Must be able to perform and review work in a manufacturing plant environment. This includes ascending/descending climbing ladders and stairs and wearing appropriate personal protective equipment. Incumbent's duties may involve internal/external work in various climate/weather conditions associated with a manufacturing plant at any time. The incumbent is expected to respond to plant emergencies when required.