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Process Engineer III

2 months ago

Chester Springs, Pennsylvania, United States National Resilience Full time
Job Summary

A career at National Resilience is more than just a job – it's an opportunity to change the future. Our company is a technology-focused biomanufacturing leader that's revolutionizing 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.

Key Responsibilities
  • Ensure technical processes are clear and deliver capable processes with centerlines, critical process parameters, material fit for use, and operating procedures.
  • Lead continuous process improvement efforts, including changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated pharmaceutical manufacturing equipment.
  • Ensure success criteria for technology transfer and validation are clear and the process is capable for the merge into the Manufacturing/Facility process.
  • Generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/reports.
  • Coordinate and support Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence. Manage the life cycle of assets.
  • Maintain external technical relationships and collaborate with equipment and material suppliers.
  • Identify, develop, generate, and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations.
  • Perform and maintain risk management activities for new and existing processes/equipment.
  • Initiate deviations and perform/facilitate technical investigations and assessment of impacts.
  • Author and review documents, including Standard Operating Procedures, Batch Records, Rework procedures, and other forms. Author, review, and approve validation and change control documents, such as master plans, protocols, summary reports, and change requests.
  • Provide input and develop user requirements for new asset procurement.
  • Offer engineering and project management services.
  • Assist in the development of project justification and engineering proposals, including providing input for capital planning process.
  • Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment.
  • Perform routine validation and periodic reviews activities.
  • Support and lead technical trouble shooting.
  • Provide on-call support as required.
  • Be the key contact for regulatory inspections as the technical process owner.
  • Participate in annual product review process.
  • Participate in biennial critical systems review process.
  • Be responsible for process validation required as a result of changes to validated processes within Manufacturing.Requirements
    • Experience in GMP or regulated production environment.
    • Training or experience in applicable technologies, including mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, and applied statistics.
    • Proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.
    Preferred Qualifications
    • Bachelor's Degree in Engineering or related science.
    • Project management experience.
    • Ability to challenge and adapt current approaches/ways of doing things.
    • Experience in Six Sigma/analytical trouble shooting skills.
    • Experience working in a LEAN manufacturing environment.
    • Expertise in more than one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.
    • Ability to coach and mentor peers.

National 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.

National Resilience offers employees a robust total rewards program, including equity, 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, family building benefits, life and disability insurance, flexible time off, 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 to $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 National Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.