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Automation Engineer

2 months ago

Sanford, United States Kyowa Kirin Full time

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.

Summary of Job:

The Automation Engineer III is responsible for designing, commissioning, and operating key automated systems within the KKNA Manufacturing Facility.

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.

Essential Functions:

Technical Skills, Knowledge, and Experience

  • Supervise design, implementation and commissioning of automated manufacturing systems, through FAT/SAT, verification testing and operational support
  • Take ownership of critical process and utility systems and maintain a ‘cradle-to-grave‘ accountability for the systems assigned, from design through operations acceptance.
  • Perform troubleshooting of I/O networks, processor configuration 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 preparation of maintenance and qualification plans.
  • Manage technical and engineering changes (change control).
  • Support internal and external audits.

Job Requirements:

Education

  • Bachelor‘s degree qualified in Chemical, Electrical, or biotechnology engineering or related field.

Experience

  • Minimum 3 years‘ experience as an automation engineer in Pharma, Biopharma, and/or Life Science industries in a capital project or manufacturing/operations role.
  • Experience in the configuration of Programmable Logic Controllers (PLC), Human Machine Interface (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 starting up and operating 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.

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 knowledge sharing, maintaining a growth mindset. Foster inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by acknowledging achievements and promoting a 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. Maintain a results-oriented approach by setting clear goals, tracking progress, and ensuring that 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 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 in Sanford, NC.

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (‘Controller‘), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing . Controller‘s data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controller‘s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (‘GDPR‘) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller‘s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at .

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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