Process Engineer
- Take overall responsibility for the safe design and safe operation of the equipment within the area.
- Provide engineering expertise as active member of area process team.
- Obtain technical expertise of equipment and processes in area of responsibility. This includes clear understanding of equipment flow chart/process flow document, critical process parameters, and master formula instructions for the process.
- Establish & monitor/trend control systems as tool for verifying and optimizing equipment performance.
- Lead troubleshooting efforts to resolve more difficult equipment and operational problems.
- The Maintenance Tech/Engineering Tech is the first line of support in troubleshooting and involves the Process Engineer as needed.
- Utilize formal problem solving techniques, including Root Cause Analysis, to resolve equipment issues.
- Respond to and implement customer requests related to the equipment.
- Communicate effectively with others, especially process team members, customers, engineering tech, and crafts personnel.
- Provide oversight to Maintenance Tech/Engineering Tech(s) that support the area.
- Evaluate all activities for impact on qualified state of equipment 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 CAPA’s.
- Participate in Periodic Reviews for equipment.
- Lead or participate in IQ/OQ/PQ 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.
- Coordinate with site/corporate asset management personnel to replicate improvements and assure alignment of maintenance and other equipment activities.
- Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.) associated with equipment within the area.
- Compare equipment performance data with that of other operations to determine areas of opportunity.
- Goals/objectives should target world-class levels of operation for safety, quality and customer service.
- Bachelor’s degree in Engineering, Computer Technology, Life Science or a related field
- Strong computer skills in a variety of software packages (Excel, JMP, etc.).
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- Previous experience in Pharmaceutical Manufacturing.
- Ability to apply statistical thinking concepts to the analysis of manufacturing problems.
- Experience working with validated systems.
- Experience in utilizing root cause analysis techniques for the systematic solving of problems.
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