Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Please note: This is not a hybrid or remote role.
Summary of Job:
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. In this role, you will collaborate closely with our team, demonstrating compassion and integrity in all your work. You will utilize your ability to facilitate alignment among diverse viewpoints to make informed decisions and drive consensus. By fostering a positive and inclusive environment, you will navigate change and uncertainty with resilience and clarity, contributing to your team's ability to adapt to rapidly evolving, fast-scaling environments and meet new challenges in the biotech industry.
Essential Functions:
Technical Skills, Knowledge, and Experience
- Provide hands-on support and guidance of installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility.
- Take system ownership within Upstream Processing, Downstream Processing, or Solution Preparations and maintain a "cradle-to-grave" accountability for the systems assigned, from design through operations acceptance.
- Create, review, and approve documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.
- Participate in the facility's Operational Readiness (OR) planning and execution.
- Collaborate with manufacturing, manufacturing sciences, and automation to evaluate new product introductions.
- Assist with preparation of maintenance, calibration, and qualification plans.
- Manage technical and engineering changes (change control).
- Support internal and external audits.
Job Requirements:
Education
Bachelor's degree qualified in Chemical, Mechanical, or biotechnology engineering or 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
Demonstrate empathetic communication by actively listening and considering others' perspectives to foster productive and engaging interactions, while managing relationships with kindness and care. Embrace personal growth through continuous learning and sharing knowledge, maintaining a growth mindset. Foster inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by acknowledging achievements and promoting healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Be resourceful and proactive in challenging the status quo, driving innovation, and developing creative solutions. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding the team through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic, while demonstrating cultural sensitivity and the ability to build alignment in a global environment. Maintain an enterprise-wide, holistic mindset, working beyond siloed thinking to drive cohesive, integrated solutions.
Physical Demands:
Initially working on a construction site and ultimately in a biotech manufacturing site.
Work is 100% on-site. This is not a hybrid or remote role.
Working Conditions:
Requires up to 10% domestic and limited international travel.
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
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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