Process Engineer III, Electromechanical (Night Shift)

Resilience • West Chester, OH

80d • $80,000 - $121,250

About The Position

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 changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Requirements

• Experience in GMP or regulated production environment.
• 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 troubleshooting, 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.

Nice To Haves

• Bachelor’s degree in engineering, or related science.
• Project management experience.
• Uses their insight to challenge and adapt current approaches/ways of doing things.
• Experience in Six Sigma/analytical troubleshooting skills.
• Experience working in a LEAN manufacturing environment.
• Expertise in more than one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.
• Ability to coach and mentor peers.
• 4 to 11 years’ experience in engineering role.

Responsibilities

• Ensures there are two technical processes (i.e. Prep and filling) with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process.
• Leads 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.
• Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence.
• Manages life cycle of assets.
• Maintains external technical relationships and collaborates with equipment and material suppliers.
• Identifies, develops, generates and manages implementation of appropriate change controls to improve processes and address root causes identified in investigations.
• Performs and maintains risk management activities for new and existing processes/equipment.
• Initiates deviations and performs/facilitates the technical investigations and assessment of impacts.
• Authors and reviews documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms.
• Authors, reviews and approves 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.
• Provides engineering and project management services.
• Assists in the development of project justification and engineering proposals including providing input for capital planning process.
• Identifies and supports technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment.
• Performs routine validation and periodic reviews activities.
• Supports and leads technical troubleshooting.
• Acts as the 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 Manufacturing.

Benefits

• Annual cash bonus program.
• 401(k) plan with a generous company match.
• Healthcare benefits including medical, dental and vision.
• Family building benefits.
• Life and disability insurance.
• Flexible time off.
• Paid holidays.
• Other paid leaves of absence.
• Tuition reimbursement.
• Support for caregiving needs.

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree