Process Engineer III - Sterile Operations (Night Shift))

Resilience•West Chester, OH

3d•Onsite

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. The Process Engineer III, Sterile Operations leads improvement initiatives across multiple assigned sterile manufacturing processes and serves as the primary escalation point for complex technical issues within the Sterile Operations function. 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. Operates independently with established GMP expertise, serving as a technical advisor and coaching resource across the function.

Requirements

Demonstrated GMP experience in a sterile or aseptic regulated manufacturing environment - not just exposure.
Hands-on, applied experience across multiple of the 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, sterile fill-finish, lyophilization, autoclave/sterilization, process validation, cleaning validation, technology transfer, change control, and applied statistics.
Demonstrated proficiency in at least one of the following disciplines: automation/controls, aseptic fill-finish equipment, sterile process/materials, maintenance, or validation.
Demonstrated ability to independently lead technical troubleshooting and continuous improvement efforts across multiple processes, applying structured problem-solving to issues that extend beyond established procedures.
Demonstrated ability to coach and mentor peers on technical processes and GMP practices.
Demonstrated ability to serve as a point of escalation for complex technical issues beyond the scope of less experienced engineers.
Employees must have the ability to demonstrate and maintain gown qualification standards.

Nice To Haves

Bachelor’s degree in Engineering or related science.
4+ years of relevant experience in sterile or aseptic GMP manufacturing, with expertise in more than one of the following disciplines: automation/controls, aseptic fill-finish equipment, sterile process/materials, maintenance, or validation.
Experience in project management.
Challenges and adapts current approaches, applying independent technical judgment across projects.
Experience in Six Sigma/analytical troubleshooting skills.
Experience working in a LEAN manufacturing environment.

Responsibilities

Ensures there is one technical process with centerlines, critical process parameters, material fit for use, and operating procedures that are clear and deliver a capable sterile manufacturing process across multiple assigned processes.
Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated sterile pharmaceutical manufacturing equipment.
Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, efficiencies, and obsolescence; manages asset life cycles, develops user requirements for new asset procurement, and maintains technical relationships with equipment and material suppliers.
Leads engineering and project management across multiple assigned capital and process improvement projects, including project justification, engineering proposals, and capital planning input.
Ensures success criteria for technology transfer and validation are clear, and the process is capable for introduction into manufacturing.
Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports.
Authors, reviews, and approves validation and change control documents such as master plans, protocols, summary reports, and change requests.
Performs routine validation and periodic review activities, including process validation required by changes to validated sterile manufacturing processes.
Leads technical troubleshooting for assigned sterile manufacturing processes and equipment.
On-call support as required.
Identifies, develops, and manages implementation of change controls to improve processes and address root causes identified in investigations.
Performs and maintains risk management activities for new and existing sterile manufacturing processes and equipment.
Initiates deviations and performs or facilitates technical investigations and assessment of impacts across multiple assigned processes, serving as the escalation point for complex investigations.
Authors and reviews Standard Operating Procedures, Batch Records, Rework procedures, and other quality documentation.
Serves as key contact for regulatory inspections as technical process owner.
Participates in periodic product and systems review processes, including annual product reviews and biennial critical systems reviews.
Leads technical training, serving as the escalation point for complex training needs, for Operations, Engineering, and Maintenance on new and existing sterile manufacturing processes and equipment.
Coaches and mentors Process Engineer I and II team members on technical processes and GMP practices.