Process Engineer II; MSAT - Dayshift

Job Summary

The Process Engineer II will handle execution of technical aspects of product and/or process technology transfer to the site through successful completion of PPQ. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process to manufacturing.

Individuals in this role work closely with facilities, Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards. After completion of PPQ, the Process Engineer leads improvement initiatives as the technical expert and acts as the first line of support for all project related work.

Responsible for maintaining a strong relationship with Technical Operations and Quality areas, as well as collaborating within Manufacturing and the Facility and with other Engineers. Serves as the single point of contact for all technical issues.

• 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.
• Provides input and develops user requirements for new asset procurement.
• Provide engineering and project management services.
• Assist in the development of project justification and engineering proposals including providing input for capital planning process.
• 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 troubleshooting.
• On-call support as required.
• Key contact for regulatory inspections as technical process owner.
• 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.

• 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 support manufacturing operations through data analysis, deviation investigations, and root cause analysis.
• Ability to develop proficiency in all the following disciplines: automation/ controls,…