Process Engineer III - Serialization
Resilience, Frankfort, KY, United States
.Process Engineer III - Serialization page is loaded## Process Engineer III - Serializationlocations:
USA - OH - West Chestertime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-106761A 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**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.***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.
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USA - OH - West Chestertime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-106761A 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**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.***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.
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