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Senior Process Engineer

2 months ago

Toledo, Toledo, United States Resilience Corp. Full time

Join Resilience Corp. as a Senior Process Engineer

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's transforming the way medicine is produced.

We are developing a sustainable network of advanced, end-to-end manufacturing solutions to better withstand disruptive events, facilitate scientific discovery, and reach those in need.

Position Overview:
This role encompasses various engineering functions including automation, production/process engineering, packaging engineering, and validation engineering. The Senior Process Engineer is accountable for ensuring the existence of a singular technical process within the PET/Facility, which includes equipment, materials, processes, and procedures with applicable validation.

Key Responsibilities:
- Act as the primary technical expert and first line of support for all project-related work.
- Maintain strong collaborative relationships with Technical Operations and Quality teams within the PET/Facility and with other PET Engineers.
- Ensure clarity in technical processes, including centerlines, critical process parameters, material suitability, and operating procedures to deliver a capable process.
- Lead continuous process improvement initiatives focused on:
- Changeover reduction
- Yield enhancements
- Overall Equipment Effectiveness (OEE) improvements
- Maintenance reliability
- Waste reduction for automated pharmaceutical manufacturing equipment.

- Ensure success criteria for technology transfer and validation are well-defined and that processes are capable of integration into the PET/Facility operations.

Additional Responsibilities:
- Generate various documents including User Requirement Specifications (URS), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols and reports.
- Coordinate and support PET/Facility improvement initiatives that define equipment data, capabilities, utilization, efficiencies, and obsolescence.
- Manage the lifecycle of assets and maintain external technical relationships with equipment and material suppliers.
- Identify, develop, and implement appropriate change controls to enhance processes and address root causes identified in investigations.
- Conduct risk management activities for new and existing processes/equipment.

Qualifications:
- Training or experience in relevant technologies such as mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, and computerized systems.
- Extensive experience in a GMP or regulated production environment.
- Expertise in at least one of the following areas: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.

Preferred Qualifications:
- A minimum of 4 years of experience in a GMP or regulated production environment.
- A Bachelor’s degree in Engineering or a related field.
- Ability to develop proficiency across multiple disciplines including automation/controls, aseptic/packaging equipment, process/materials, maintenance, and validation.
- Capability to coach and mentor peers.

Resilience Corp. is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, protected veteran status, disability status, or any other non-job-related characteristics.

Resilience offers a comprehensive total rewards program, including equity, an annual cash bonus program, a 401(k) plan with a generous company match, and a thoughtfully designed benefits package to support our employees with excellent healthcare, family building benefits, life and disability insurance, flexible time off, paid holidays, tuition reimbursement, and support for caregiving needs.