Process Engineer

Position Description, Functions, Duties, and Tasks:

· Provide day-to-day support of upstream purification manufacturing operations, including resolution of manufacturing deviations and troubleshooting process issues.

· Provide automation technical support to upstream purification 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.

· Act as user representative for capital projects or delivery agent for local projects.

· Understand equipment reliability issues with the objective of improvement.

· Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with processes within the area.

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 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.

Additional Preferences:

· Configuration and programming experience with Emerson PROVOX and DeltaV control systems.

· Experience with Data Historian such as AspenTech Process Explorer or similar system.

Preferred Qualifications:

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

Other Information:

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. 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.