Senior Process Engineer

Kyowa Kirin • Sanford, NJ

1d • Onsite

About The Position

The Senior Process Engineer is responsible for the design, commissioning, and operation of the KKNA Manufacturing Facility, including technology transfer, process definition, troubleshooting, and process optimization. The role will help start up a new state-of-the-art facility and deliver reliable, compliant equipment and systems for manufacturing in alignment with site objectives and regional and global standards.

As an individual contributor, the engineer collaborates across teams, takes ownership of assigned work, adapts to challenges, and contributes to a supportive and inclusive environment. The role supports downstream processing and drug substance manufacturing, from system design through operational acceptance, while keeping patient needs and organizational values central to the work.

Requirements

• Bachelor’s degree in Chemical, Mechanical, Biotechnology Engineering, or a related field.
• At least 5 years of experience as a process engineer in Pharma, Biopharma, and/or Life Science industries in a manufacturing or operations role.
• Knowledge and experience with Single Use Technology (SUT), preferably in monoclonal antibody (mAb) processing.
• Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to clinical and commercial manufacturing.
• Proficiency in MS Office Suite.
• Ability to organize, prioritize, meet deadlines, make decisions, and adjust course quickly.
• Strong interpersonal and written and verbal communication skills, strong work ethic, and attention to detail with 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.
• Ability to work on-site at a construction site initially and ultimately at a biotech manufacturing site in Sanford, NC.
• Willingness to travel domestically and internationally up to 10%.

Nice To Haves

• Experience starting up and operating a biopharma 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 operations acceptance.
• 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 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 paid time off 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior