Process Engineer II

Job Description

Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process.

• Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment.
• Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the Manufacturing/Facility process.
• Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/reports.
• Coordinate and support Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence. Manages life cycle of assets.
• Maintain external technical relationships and collaborates with equipment and material suppliers.
• Identify, develop, generate, and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations.
• Perform and maintain risk management activities for new and existing processes / equipment.
• Initiate deviations and performs/facilitates the technical investigations and assessment of impacts.
• Authors and review documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms. Author, review and approve validation and change control documents such as master plans, protocols, summary reports and change requests.
• Provide engineering and project management services.
• Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment.
• Perform routine validation and periodic reviews activities.
• Supports and leads technical trouble shooting.
• On-call support as required.
• Participates in annual product review process.
• Participates in biennial critical systems review process.
• Responsible for process validation required because of changes to validated processes within Manufacturing.

Minimum Requirements

• Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics.
• Ability to develop proficiency in all the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.

Preferred Background

• Bachelor's degree in engineering, or related science
• Experience in GMP or regulated production environment.
• Experience in Project management
• Uses their insight to challenge and adapt current approaches/ways of doing things.
• Experience in Six Sigma/analytical trouble shooting skills.
• Experience working in a LEAN manufacturing environment.
• 2 to 5 years' experience