Senior Process Engineer
About The Position
The Senior Process Engineer is responsible for the design, commissioning, and operation of Kyowa Kirin North America’s manufacturing facility, including technology transfer, process definition, troubleshooting, and process optimization. The role helps start up a new state-of-the-art facility and delivers reliable, compliant equipment and systems that support manufacturing objectives and regional and global standards. This is an individual-contributor position requiring collaboration, accountability, adaptability, initiative, and a patient-centered approach. The position will initially be based at a construction site and ultimately at a biotech manufacturing site in Sanford, North Carolina. It is 100% on-site and requires up to 10% domestic and international travel.
Requirements
- Bachelor’s degree in Chemical, Mechanical, or Biotechnology Engineering, or a related field.
- At least 5 years of experience as a process engineer in the pharmaceutical, biopharmaceutical, and/or life sciences industries in a manufacturing or operations role.
- Knowledge and experience with Single Use Technology (SUT), preferably in monoclonal antibody processing.
- Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to clinical and commercial manufacturing.
- Proficiency in the MS Office Suite.
- Ability to organize and prioritize work, meet deadlines, make decisions, and adjust course quickly.
- Strong interpersonal and written and verbal communication skills, a strong work ethic, attention to detail, and excellent follow-through.
- Ability to adapt to change, work independently with flexibility, and manage ambiguity in a dynamic, fast-paced, high-growth environment.
- Commitment to continuous learning and development.
- Cultural sensitivity and ability to build consensus within a multinational organization.
Nice To Haves
- Experience starting up and operating a biopharmaceutical manufacturing facility.
Responsibilities
- Provide hands-on support and guidance for installation, maintenance, troubleshooting, and repair of manufacturing facility assets and systems.
- Own systems within Downstream Processing, with accountability from design through acceptance into operations.
- Draft, review, and approve operating procedures, maintenance plans, engineering drawings, and equipment specifications.
- Participate in Operational Readiness planning and execution.
- Collaborate with Manufacturing, Manufacturing Sciences, and Automation to evaluate and support new product introductions.
- Support preparation of maintenance, calibration, and qualification plans.
- Manage technical and engineering changes through the change control process.
- Support manufacturing operations through process fit assessments, troubleshooting, root cause analysis of nonconformances, and implementation of process changes and improvements.
- Drive continuous improvement of drug substance manufacturing processes through technological innovation.
- Actively support inspections and audits conducted by U.S. and other applicable regulatory agencies.
- Ensure compliance with regulatory requirements and external standards, including EHS requirements, corporate procedures, and GxP expectations.
Benefits
- 401(k) with company matching
- Annual bonus program
- Generous PTO and holiday schedule, including summer and winter shutdowns, sick days, and volunteer days
- Healthcare benefits, including medical, dental, prescription drug, and vision coverage
- HSA and FSA programs
- Well-being and work-life programs
- Long-term incentive program, subject to job level and performance
- Life and disability insurance
- Concierge service
- Pet insurance
- Tuition assistance
- Employee referral awards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
