Process Engineer III - Serialization
Resilience, Port Union, OH, United States
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.com
Position Summary
The Process Engineer III - Serialization serves as the subject matter expert (SME) for serialization systems while providing engineering support for a designated low-volume pharmaceutical production line. This role is responsible for ensuring reliable operation, compliance, and continuous improvement of serialization processes in alignment with regulatory requirements, while also driving performance, quality, and efficiency on the assigned manufacturing line.
Key Responsibilities
Project & Technical Leadership
Lead small-to-medium engineering projects, including equipment upgrades and process improvements
Support new product introductions (NPI) and technology transfers into manufacturing
Interface with external vendors and integrators for system support and enhancements
Mentor junior engineers and provide technical guidance across the team
Serialization Systems SME
Act as the site SME for serialization systems, including aggregation, vision systems, and data management platforms
Troubleshoot serialization equipment and software issues, coordinating with vendors and IT as needed
Lead and support serialization-related deviations, CAPAs, and change controls
Develop and maintain SOPs, work instructions, and training materials related to serialization processes
Support audits and inspections by regulatory agencies and clients
Manufacturing Line Support
Provide daily engineering support for an assigned low-volume production line
Troubleshoot equipment and process issues to minimize downtime and maintain production schedules
Lead or support root cause investigations and implement corrective actions
Drive continuous improvement initiatives focused on safety, quality, and efficiency
Collaborate with Operations, Quality, Maintenance, and Supply Chain to ensure smooth execution of production
Support process validation activities, including IQ/OQ/PQ and continued process verification
Minimum Qualifications
Hands‑on experience with serialization systems (e.g., vision systems, aggregation, Level 2/3 systems)
Strong knowledge of GxP environments and regulatory requirements (FDA, EMA)
Experience with validation (IQ/OQ/PQ), change control, and deviation management
Experience with automated inspection/packaging equipment preferred
Ability to analyze data and implement process improvements
Preferred Qualifications
Bachelor's degree in engineering (Mechanical, Chemical, Biomedical, or related field)
Experience in contract manufacturing organization (CMO/CDMO) environments
5-8+ years of experience in pharmaceutical or medical device manufacturing (contract manufacturing preferred)
Familiarity with serialization platforms (e.g., Systech)
Sponsorship or support for work authorization, including visas, is not available for this position.
Equal Employment Opportunity
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.
Benefits and Compensation
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.
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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.com
Position Summary
The Process Engineer III - Serialization serves as the subject matter expert (SME) for serialization systems while providing engineering support for a designated low-volume pharmaceutical production line. This role is responsible for ensuring reliable operation, compliance, and continuous improvement of serialization processes in alignment with regulatory requirements, while also driving performance, quality, and efficiency on the assigned manufacturing line.
Key Responsibilities
Project & Technical Leadership
Lead small-to-medium engineering projects, including equipment upgrades and process improvements
Support new product introductions (NPI) and technology transfers into manufacturing
Interface with external vendors and integrators for system support and enhancements
Mentor junior engineers and provide technical guidance across the team
Serialization Systems SME
Act as the site SME for serialization systems, including aggregation, vision systems, and data management platforms
Troubleshoot serialization equipment and software issues, coordinating with vendors and IT as needed
Lead and support serialization-related deviations, CAPAs, and change controls
Develop and maintain SOPs, work instructions, and training materials related to serialization processes
Support audits and inspections by regulatory agencies and clients
Manufacturing Line Support
Provide daily engineering support for an assigned low-volume production line
Troubleshoot equipment and process issues to minimize downtime and maintain production schedules
Lead or support root cause investigations and implement corrective actions
Drive continuous improvement initiatives focused on safety, quality, and efficiency
Collaborate with Operations, Quality, Maintenance, and Supply Chain to ensure smooth execution of production
Support process validation activities, including IQ/OQ/PQ and continued process verification
Minimum Qualifications
Hands‑on experience with serialization systems (e.g., vision systems, aggregation, Level 2/3 systems)
Strong knowledge of GxP environments and regulatory requirements (FDA, EMA)
Experience with validation (IQ/OQ/PQ), change control, and deviation management
Experience with automated inspection/packaging equipment preferred
Ability to analyze data and implement process improvements
Preferred Qualifications
Bachelor's degree in engineering (Mechanical, Chemical, Biomedical, or related field)
Experience in contract manufacturing organization (CMO/CDMO) environments
5-8+ years of experience in pharmaceutical or medical device manufacturing (contract manufacturing preferred)
Familiarity with serialization platforms (e.g., Systech)
Sponsorship or support for work authorization, including visas, is not available for this position.
Equal Employment Opportunity
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.
Benefits and Compensation
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.
#J-18808-Ljbffr