Senior Process Engineer

6 days ago

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

We are seeking a highly skilled Process Engineer III to join our team at National Resilience. As a key member of our biomanufacturing team, you will be responsible for ensuring the development and implementation of efficient and effective processes that meet our high standards of quality and safety.

Key Responsibilities
  • Process Development and Implementation: Develop and implement technical processes with clear centerlines, critical process parameters, material fit for use, and operating procedures.
  • Continuous Improvement: Lead efforts to improve process efficiency, reduce waste, and increase overall equipment effectiveness.
  • Technology Transfer and Validation: Ensure successful technology transfer and validation of processes, and ensure that processes are capable and meet regulatory requirements.
  • Protocol and Report Generation: Generate various protocols and reports, including URS, FAT, SAT, commissioning, and IQ/OQ/PQ.
  • Manufacturing and Facility Improvement: Coordinate and support initiatives to improve manufacturing and facility processes, including equipment data management, utilization, and obsolescence.
  • Technical Relationships and Collaboration: Maintain external technical relationships with equipment and material suppliers, and collaborate with internal teams to ensure effective communication and coordination.
  • Change Control and Risk Management: Identify, develop, and implement change controls to improve processes and address root causes of issues.
  • Deviations and Investigations: Initiate deviations, perform and facilitate technical investigations, and assess impacts on processes and equipment.
  • Document Authorship and Review: Author and review documents, including Standard Operating Procedures, Batch Records, and validation and change control documents.
  • Project Management and Engineering Services: Provide engineering and project management services, including input for capital planning and project justification.
  • Training and Development: Identify and support technical training requirements for Operations, Engineering, and Maintenance teams.
  • Validation and Review Activities: Perform routine validation and periodic reviews of processes and equipment.
  • Troubleshooting and On-Call Support: Support and lead technical troubleshooting efforts, and provide on-call support as required.
  • Regulatory Compliance: Serve as key contact for regulatory inspections and participate in annual product review and biennial critical systems review processes.
Requirements
  • Experience: 1-2 years of experience in a GMP or regulated production environment.
  • Training and Experience: 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.
  • Discipline Proficiency: Proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.
Preferred Qualifications
  • Education: Bachelor's Degree in Engineering or related science.
  • Project Management: Experience in project management.
  • Adaptability and Analytical Skills: Ability to challenge and adapt current approaches, and use analytical skills to troubleshoot issues.
  • Lean Manufacturing Experience: Experience working in a LEAN manufacturing environment.
  • Discipline Expertise: Expertise in more than one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, validation.
  • Coaching and Mentoring: Ability to coach and mentor peers.

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