Process Engineer III - Sterile Operations (Night Shift))

Resilience; Port Union (OH); On-site; USD 80,000 - 121,000; Full time

Benefits offered by this job

Annual bonus program

401(k) plan with company match

Healthcare including medical, dental &

Vision benefits

Paid vacation & holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience is seeking a Process Engineer III, Sterile Operations to lead improvement initiatives across multiple sterile manufacturing processes and serve as the primary escalation point for complex technical issues. This role collaborates with Technical Operations, Quality, Manufacturing, and Facility teams to ensure validated, compliant, and efficient operations.

The successful candidate will bring GMP expertise, hands-on experience in aseptic environments, and a track record of coaching peers

Qualifications

• GMP experience in a sterile or aseptic manufacturing environment
• Hands-on experience across mechanical, hydraulic, pneumatic, vacuum, electronics, and control systems
• Ability to independently lead technical troubleshooting across multiple processes
• Experience coaching peers on GMP practices and process improvements
• Proven capability to manage complex investigations and deviations

Responsibilities

• Lead process and equipment improvement across multiple sterile manufacturing processes
• Develop and execute validation and transfer activities, including URS, FAT, SAT, IQ/OQ/PQ
• Author and review validation and change control documents and SOPs
• Provide escalation support for complex technical issues and train Operations/Engineering teams
• Drive continuous improvement in changeover, yield, OEE, and waste reduction

Skills

GMP experience

Technical troubleshooting

Leadership / coaching

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or related science

Tools

Automation/controls

Aseptic fill-finish equipment

Sterile process/materials

Maintenance

Validation

Job description

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.For more information, please visit www.resilience.comThe 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.Job ResponsibilitiesProcess & Equipment ImprovementEnsures 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.Validation & Technical SupportEnsures 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.Quality Systems & ComplianceIdentifies, 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.Training & DevelopmentLeads 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.Experience & EducationMinimum QualificationsDemonstrated 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.Preferred QualificationsBachelor’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.Physical & Work EnvironmentWork may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs, as well as occasional travel.Physical demands may include prolonged sitting with occasional standing, walking, bending, stooping, twisting, and reaching; the ability to lift or carry up to 20 lbs; infrequent work at heights up to 5 ft; occasional exposure to noise, chemicals, and moving machinery; and working in cleanroom environments with appropriate gowning and personal protective equipment. The role also requires specific visual acuity (including extended computer use, color vision, and depth perception) and the ability to hear and distinguish sounds consistent with interpersonal and group conversation.Work Schedule[examples: 8 hours - Monday- Friday; 10 hours – Monday-Thursday; 12 hour – 2/2/3]The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.Sponsorship or support for work authorization, including visas, is not available for this position.Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.