Process Engineer III - Serialization

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. 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. Join Our Talent Community Don't see a posting that's the right fit? Join our talent community to be considered in our talent pool and we'll reach out if the right opportunity arises.

RESILIENCE

is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.

RESILIENCE

will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients' lives. Please Note - Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites