Senior Manufacturing Operator

Kyowa Kirin North America•Sanford, NC

9d•$33 - $45•Onsite

About The Position

Kyowa Kirin is hiring a Senior Manufacturing Operator to support the startup and execution of core operations at a greenfield biopharmaceutical site focused on rare disease therapies. The role executes complex upstream and downstream manufacturing processes in a GMP environment, models safety and compliance, supports troubleshooting and continuous improvement, and trains and mentors other manufacturing associates. The operator works collaboratively with Engineering, Automation, Quality, and other teams to build a patient-centered manufacturing platform, including hands-on involvement in equipment commissioning, process validation, and automated systems. This is an individual-contributor role that calls for initiative, adaptability, collaboration, and a focus on patients and organizational values. The position begins on a Monday–Friday day schedule during construction and commissioning, then transitions to a 2-2-3 day schedule with 12-hour shifts (7:00 AM–7:00 PM) during manufacturing operations. Work is 100% on-site, initially at a construction site and ultimately at a biopharmaceutical manufacturing facility in Sanford, North Carolina. The role requires up to 10% domestic and international travel. The anticipated pay range is $33.00–$45.00 per hour. The company describes a comprehensive benefits package, including retirement, paid time off, healthcare, insurance, well-being programs, tuition assistance, and other benefits.

Requirements

Bachelor's degree plus at least 4 years of relevant biopharmaceutical manufacturing experience; or an associate's degree plus at least 6 years; or a high school diploma/GED plus at least 8 years.
Direct upstream and downstream GMP manufacturing experience.
Relevant upstream experience, including vial thaw/inoculation, Wave bioreactors, single-use bioreactors (50L, 500L, 3000L), and harvest operations.
Relevant downstream experience, including chromatography, viral inactivation, viral filtration, TFF systems, and bulk filling.
Knowledge of Agile and Lean Manufacturing principles and Standard Work.
Proficiency with Microsoft Office applications.
Strong problem-solving and critical-thinking skills.
Ability to maintain clean manufacturing environments in accordance with GMP and safety standards.
Ability to read and interpret technical documents, troubleshoot and operate production equipment, and perform basic math and statistics.
Strong written and verbal English communication skills.
Results-oriented approach, accountability, follow-through, adaptability, and resilience in a changing environment.
Strong organizational skills and attention to detail; communication and interpersonal skills; and ability to collaborate across diverse teams and perspectives.
Commitment to continuous learning, knowledge sharing, innovation, process improvement, inclusive relationships, and collective success.
Ability to lift up to 35 pounds, move heavy objects, and stand for three or more hours while operating equipment.
Ability to meet gowning and PPE requirements.

Nice To Haves

Bachelor's degree in a technical field such as Chemical Engineering, Chemistry, Biology, or a related discipline.
Experience supporting startup and operation of a biopharmaceutical manufacturing process.
Experience authoring or editing SOPs.
Experience with electronic records and PCS software such as DeltaV, Unicorn, Ignition, or similar systems.

Responsibilities

Execute mAb manufacturing operations on the manufacturing floor, including weigh and dispense, bioreactors, filtration, inoculum preparation, chromatography skids, and UF/DF skids using PCS and MES.
Follow safety and compliance policies, cGMP requirements, applicable regulations, and ALCOA+ data integrity practices.
Follow operating procedures, master records, and supervisor instructions; maintain accurate batch records, log sheets, and other documentation.
Escalate actual or perceived non-compliance events promptly.
Collaborate with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams to support compliant and efficient commissioning and manufacturing operations.
Develop operational SOPs, participate in FATs, and support equipment validation and qualification with Engineering teams.
Identify and implement process improvements; lead initiatives to streamline workflows and eliminate waste.
Use enterprise systems supporting manufacturing, including ERP, LIMS, MES, PCS, QMS, and BMS.
Lead floor troubleshooting and resolution of equipment, automation, and process issues; support CAPA tracking and documentation.
Maintain clean and organized manufacturing areas through routine cleaning and preventative maintenance.
Manage shop-floor activities using 5S, Standard Work, and Kanban methodologies.
Coordinate with Warehouse and Maintenance to ensure availability of materials, supplies, and equipment.
Train new colleagues and junior staff in manufacturing processes, equipment operation, safety, and company standards.
Assist with technical transfer activities for new products and manufacturing processes.