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Resilience · 20 hours ago

Process Engineer II

West Chester, OH

Full-time

Onsite

Mid Level

$70K/yr - $96K/yr

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Process Engineer II is responsible for ensuring technical processes within the PET/Facility, leading improvement initiatives, and acting as the first line of support for project-related work.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

Ensures there is one 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 PET/Facility process

Generates a variety of URS, FAT, SAT, commissioning and IQ/OQ/PQ protocols/ reports

Coordinate and support PET’s/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

Works collaboratively within PET as well as with other PET Engineers and Technology Community such as Technology and Engineering, global colleagues

Supports and leads technical trouble shooting

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 as a result of changes to validated processes within the PET

Qualification

Process validationChange controlTechnical troubleshootingAutomation/controlsAseptic/packaging equipmentMechanical aptitudeExternal technical relationshipsCommunication skillsTeam collaboration

Required

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

Proficiency in at least one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation