Process Engineer III, Serialization - IDAP

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

The Process Engineer III independently leads improvement initiatives as the technical expert and primary escalation point across multiple project workstreams. Maintains strong relationships with Technical Operations and Quality, collaborates cross-functionally within Manufacturing and the Facility, and mentors junior engineers. Serves as the single point of contact for complex technical issues requiring independent judgment.

Job Responsibilities

Process & Equipment Improvement

• Independently owns technical processes across multiple assigned IDAP products and lines; proactively identifies and resolves process gaps and drives convergence to one technical process without direction from senior engineers.
• Independently identifies and leads continuous improvement workstreams across multiple IDAP processes, applying structured problem-solving (e.g., DMAIC, RCA) to define root causes and drive improvements.
• Independently leads Manufacturing and Facility improvement initiatives for assigned IDAP process areas, defining equipment capability requirements, driving utilization improvements, and managing the full asset lifecycle.
• Independently manages engineering projects from initiation to completion for assigned IDAP processes, developing project justification and proposals, managing resources and timelines, and contributing to capital planning.

Validation & Technical Support

• Independently leads technology transfer and validation activities for assigned processes from commissioning through PPQ, owning success criteria definition, process characterization, and capability assessment at each phase gate.
• Authors, reviews, and independently approves URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned process areas.
• Leads validation activities and periodic reviews for assigned processes, independently evaluating compliance status and driving corrective actions.
• Leads complex technical troubleshooting across multiple IDAP processes, developing systematic approaches to recurring issues, including on-call support as required.
• Independently manages external technical relationships with equipment and material suppliers for assigned IDAP processes, evaluating supplier solutions and driving resolution of technical issues without escalation.

Quality Systems & Compliance

• Independently leads change control development and implementation for assigned process areas, evaluating cross-functional impact and applying risk-based judgment to change decisions.
• Independently performs and maintains risk management activities for assigned processes, applying structured risk assessment tools to prioritize mitigation activities.
• Leads complex technical investigations across multiple assigned processes, applying structured problem-solving to identify root causes and define CAPAs.
• Authors, reviews, and independently approves controlled documents including SOPs, Batch Records, and Rework procedures for assigned process areas.
• Serves as the key technical contact for regulatory inspections for assigned process areas, independently preparing technical responses and process documentation.
• Participates in the annual product review process.

Training & Development

• Designs and delivers technical training programs for Operations, Engineering, and Maintenance for assigned IDAP process areas, ensuring content is current and aligned with validated procedures.
• Coaches and mentors Process Engineer I and II engineers on technical processes, GMP practices, and problem-solving methodology.

Experience & Education

Minimum Qualifications

• Demonstrated GMP experience in a regulated pharmaceutical manufacturing environment, with the ability to independently apply controlled procedures, quality standards, and deviation management practices.
• Prior training or hands-on experience in one or more IDAP-relevant technologies, such as automation/controls (PLCs, HMI, computerized systems), aseptic/controlled environments, packaging equipment, process or cleaning validation, or change control.
• Demonstrated proficiency in more than one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.
• Demonstrated ability to coach and mentor peers on technical processes, GMP practices, and problem-solving methodology.
• Demonstrated ability to independently lead technical troubleshooting and continuous improvement efforts for assigned IDAP processes.

Preferred Qualifications

• Bachelor's degree in Engineering or related science, and 4+ years of experience in a GMP or regulated pharmaceutical manufacturing environment, with demonstrated proficiency in at least one IDAP engineering discipline.
• Demonstrated project management capability, including experience managing engineering workstreams from initiation to delivery.
• Six Sigma or analytical troubleshooting experience.
• Experience working in a Lean manufacturing environment.
• Proficiency in one or more serialization platforms such as SAP ATTP, Rfxcel, etc., with a focus on configuration and integration in new deployments.
• Strong experience with vendor management during new line installation, particularly concerning serialization equipment and software providers.
• Hands-on experience with the installation and integration of Level 1 hardware components (printers, scanners, vision systems) and Level 2 line control systems on new and existing packaging lines.

Physical & Work Environment

• Work 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 the use of 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.