About the position
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. The Sr. Automation Engineer is responsible for the design, commissioning, and operation of key KKNA Manufacturing Facility automated systems. As an individual contributor, you will embody a compassionate, people-centric approach in your interactions with colleagues, enhancing team dynamics while fostering an inclusive and collaborative environment. Your work will reflect the organization's values and integrity in every action. By leveraging emotional intelligence and situational awareness, you will engage with diverse perspectives, manage relationships, and make empathetic decisions that address the needs of both individuals and the team. Results-oriented and adaptable, you will contribute to measurable outcomes that align with business objectives. Additionally, you will partner with your colleagues to navigate change and uncertainty, helping them build resilience and clarity to thrive in a rapidly evolving biotech environment with a patient-focused mindset.
Responsibilities
- Supervise the design, implementation, and commissioning of automated manufacturing systems through FAT/SAT, verification testing, and operational support.
- Take ownership of critical process and utility systems, maintaining 'cradle-to-grave' accountability for the assigned systems from design through operations acceptance.
- Contribute to the management of contracted suppliers, coordinating with construction managers.
- Perform troubleshooting of I/O networks, processor configurations, and batch recipe programs.
- Create, review, and approve documentation such as operational procedures, maintenance plans, engineering drawings, user requirements, and system specifications.
- Participate in the facility's Operational Readiness (OR) planning and execution.
- Collaborate with manufacturing, manufacturing sciences, and process engineers to evaluate new product introductions.
- Assist with the preparation of maintenance and qualification plans.
- Manage technical and engineering changes (change control).
- Support internal and external audits.
Requirements
- Bachelor's degree qualified in Chemical, Electrical, or biotechnology engineering or related field.
- Minimum 5 years of experience as an automation engineer in the pharmaceutical, biopharma, and/or life sciences industries in a capital project or manufacturing/operations role.
- Experience in the configuration of Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), and Supervisory Control and Data Acquisition (SCADA) systems.
- Knowledge and experience with the assessment of and compliance with Data Integrity (DI) requirements.
- Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to both clinical and commercial manufacturing.
- Experience making system configuration changes under an engineering change control process.
Nice-to-haves
- Experience with MES system design and implementation.
- Experience with the startup and operation of a biopharma manufacturing facility.
- Experience in programming Rockwell PLC.
- Experience in programming SCADA (e.g. Ignition, FactoryTalk, Wonderware).
- Proficient in MS Office Suite.
