Senior Automation Engineer

Kyowa Kirin is a fastgrowing global specialty pharmaceutical company that applies stateoftheart biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japanbased 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.

Summary of Job:

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 peoplecentric approach in your interactions with colleagues enhancing team dynamics while fostering an inclusive and collaborative environment. Your work will reflect the organizations 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. Resultsoriented 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 patientfocused mindset.

Essential Functions:

Technical Skills Knowledge and Experience

• 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 cradletograve 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 facilitys Operational Readiness (OR) planning and .
• 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.

Subordinates: Individual contributor with the opportunity to potentially lead or coordinate task teams.

Job Requirements:

Education

• Bachelors degree qualified in Chemical Electrical or biotechnology engineering or related field

Language Requirement:

• Proficiency in Japanese (businesslevel or higher) is required for this role as it involves regular communication with Japanesespeaking clients and team members.

Experience

• 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.
• Experience with MES system design and implementation is a plus.
• Experience with the startup and operation of a biopharma manufacturing facility is a plus.

Technical Skills

• Experience in programming Rockwell PLC
• Experience in programming SCADA (e.g. Ignition FactoryTalk Wonderware)
• Proficient in MS Office Suite.

NonTechnical 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 worklife 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. Maintain a resultsoriented approach by setting clear goals tracking progress and ensuring your actions consistently lead to measurable outcomes that advance organizational objectives. 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 enterprisewide 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 in Sanford NC.

Work is 100 onsite. 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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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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