Manufacturing Operator II

About the Role

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario.

• Serve as a role model for safety and GMP compliance.
• Execute biomanufacturing processes in a regulated environment, including upstream and/or downstream operations.
• Participate in equipment commissioning, process validation, and automation implementation activities.
• Collaborate with Engineering, Automation, and Quality teams to support operational readiness.
• Assist with troubleshooting and contribute to continuous improvement initiatives.
• Ensure compliance with regulatory standards and adherence to established procedures.
• Train and support other manufacturing associates to promote team development and operational consistency.
• Contribute to building a high‑performing, patient‑centered manufacturing platform from the ground up.
• Execute manufacturing operations in accordance with standard work and work instructions for monoclonal antibody (mAb) production, including weigh and dispense, buffer and media preparation, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and/or UF/DF skids via PCS and MES systems.
• Perform all tasks in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+).
• Follow operational procedures and master batch records; maintain accurate documentation, including batch records and logbooks.
• Escalate any actual or perceived non‑compliance events, equipment issues, or process deviations promptly.
• Collaborate with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams during commissioning and routine manufacturing.
• Assist with equipment validation and qualification activities.
• Identify opportunities for process improvement and contribute to initiatives that enhance operational efficiency.
• Demonstrate working knowledge of enterprise systems such as ERP, LIMS, MES, PCS, QMS, and BMS.
• Assist with on‑floor troubleshooting and resolution of equipment, automation, and process‑related issues; support CAPA documentation as needed.
• Maintain cleanliness and organization of the manufacturing area through routine cleaning and preventive maintenance in compliance with GMP and safety standards.
• Apply 5S, standard work, and Kanban principles; coordinate with Warehouse and Maintenance teams to ensure availability of materials and equipment.
• Train and mentor new team members in manufacturing processes, equipment operation, safety procedures, and company standards.
• Participate in the technical transfer of new products and processes into the manufacturing area.

• Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with relevant experience in biopharmaceutical manufacturing.
• Associate degree in a technical field and at least 2 years of relevant experience in biopharmaceutical manufacturing.
• High school diploma or equivalent and at least 4 years of relevant experience in biopharmaceutical manufacturing.
• Experience with start‑up and operation of biopharmaceutical manufacturing processes is a plus.
• Experience with core unit operations such as solution preparation, inoculation, and weigh & dispense.
• Exposure to upstream and/or downstream bioprocessing operations preferred.
• Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work, preferred.
• Basic technical writing skills (reviewing/editing SOPs) and proficiency in Microsoft Office applications (Word, Excel, Outlook).
• Strong problem‑solving and critical thinking abilities.
• Experience with authoring or editing…