Summary:The Senior Process Engineer is responsible for the design, commissioning, and operation of the KKNA Manufacturing Facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. You will be responsible for helping start up the new state-of-the-art facility, delivering reliable and compliant equipment and systems used in manufacturing to drive the site objectives and align to regional and global standards. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization's values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
Essential Functions:Technical Skills, Knowledge, and Experience
• Provide hands-on support and guidance for the installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility.
• Assume system ownership within Downstream Processing, maintaining cradle-to-grave accountability from design through operations acceptance.
• Draft, review, and approve documentation, including operating procedures, maintenance plans, engineering drawings, and equipment specifications.
• Participate in Operational Readiness (OR) 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 the 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 applicable regulatory requirements and external standards, including EHS requirements, corporate procedures, and GxP expectations.
Requirements:Education
Bachelor's degree in Chemical, Mechanical, Biotechnology Engineering, or a related field.
Experience
• Minimum 5 years' experience as a process engineer in Pharma, Biopharma, and/or Life Science industries in a manufacturing/operations role.
• Knowledge and experience of Single Use Technology (SUT), preferably in monoclonal antibody (mAb) processing. Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to both clinical and commercial manufacturing.
• Experience with starting up and operating a biopharma manufacturing facility is a plus.
Technical Skills
Proficient in MS Office Suite.
Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and adjust course quickly. Strong interpersonal and written/verbal communication skills; strong work ethic; and attention to detail with excellent follow-through. Ability to work and adapt through change, execute work independently with flexibility, and manage ambiguity in a dynamic, fast-paced, high-growth environment. Commitment to continuous learning and development. Cultural sensitivity and the ability to build consensus within a multinational organization.
Physical Demands:This role will initially work on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
Work is 100% on-site. This is not a hybrid or remote role.
Working Conditions:Requires up to 10% domestic and international travel
The anticipated salary for this position will be
$130,000 to $145,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:
- 401K with company matching
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program (subject to job level and performance)
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
#LI-TT1 #OnSite #Sanford #North Caroling
