Process Engineer

PROCESS ENGINEER

Position Description Functions Duties and Tasks:

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.

Experience:

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.).

Required Skills:

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.

Physical Demand Requirements:

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. Incumbents 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.

What do we offer

• 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

Required Experience:

IC