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Kyowa Kirin, Inc.- U.S. · 2 days ago

Manufacturing Operator I

Sanford, NC

Full-time

Onsite

Entry Level

2+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company focused on delivering novel medicines. They are seeking a Manufacturing Operator I to support a greenfield biopharmaceutical site dedicated to rare disease therapies, executing biomanufacturing processes and ensuring compliance with safety and GMP standards.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Serve as a role model for safety and GMP compliance

Execute biomanufacturing processes in a regulated environment

Participate in equipment commissioning, process validation, and automation activities

Collaborate cross-functionally with Engineering, Automation, and Quality teams

Assist with troubleshooting and contribute to continuous improvement initiatives

Ensure compliance with regulatory standards and adherence to established procedures

Contribute to building a high-performing, patient-centered manufacturing platform from the ground up

Executes manufacturing operations utilizing standard work on the manufacturing floor for monoclonal antibodies (mAb) manufacturing including weigh and dispense, buffer and media prep, bioreactors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids via PCS and MES

Performs all tasks in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as other applicable regulatory requirements

Follows operational procedures and master batch records; adheres to written and verbal instructions from supervisors. Maintains accurate documentation, including batch records, logbooks, and other required records

Escalates any actual or perceived non-compliance events, equipment issues, or process deviations in a timely and appropriate manner

Ensures compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX and Warehouse teams

Identifies opportunities for process improvement and contributes to initiatives that enhance operational efficiency and reduce waste

Demonstrates working knowledge of enterprise systems such as ERP, LIMS, MES, PCS, QMS, and BMS

Assists with on-the-floor troubleshooting and resolution of equipment, automation, and process-related issues; supports CAPA documentation as needed

Maintains cleanliness and organization of the manufacturing area by executing routine cleaning and preventative maintenance to ensure compliance with GMP and safety standards

Applies 5S, standard work, and Kanban principles to maintain an organized and efficient shop floor. Coordinates with Warehouse and Maintenance teams to ensure availability of materials and equipment

Participate in the technical transfer of new products and processes into the manufacturing area

Qualification

Biopharmaceutical manufacturingGMP complianceProcess validationEquipment troubleshootingStandard Operating ProceduresData Integrity principlesEnterprise systems knowledgeLean manufacturing principlesProblem-solving skillsInterpersonal skillsOrganizational skillsAttention to detailCommunication skillsAdaptability

Required

High school diploma or equivalent and at least 2 years of relevant experience in biopharmaceutical manufacturing

Follows operational procedures and master batch records; adheres to written and verbal instructions from supervisors

Maintains accurate documentation, including batch records, logbooks, and other required records

Escalates any actual or perceived non-compliance events, equipment issues, or process deviations in a timely and appropriate manner

Ensures compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX and Warehouse teams

Identifies opportunities for process improvement and contributes to initiatives that enhance operational efficiency and reduce waste

Demonstrates working knowledge of enterprise systems such as ERP, LIMS, MES, PCS, QMS, and BMS

Assists with on-the-floor troubleshooting and resolution of equipment, automation, and process-related issues; supports CAPA documentation as needed

Maintains cleanliness and organization of the manufacturing area by executing routine cleaning and preventative maintenance to ensure compliance with GMP and safety standards

Applies 5S, standard work, and Kanban principles to maintain an organized and efficient shop floor

Coordinates with Warehouse and Maintenance teams to ensure availability of materials and equipment

Participate in the technical transfer of new products and processes into the manufacturing area

Must be able to lift up to 35 lbs and move heavy objects such as material containers, bagged product, and pallets

Must also be able to stand for 3 or more hours while operating equipment

Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE

Requires up to 10% domestic and international travel

Preferred

Associate degree in a technical field with relevant experience in biopharmaceutical manufacturing

BioWorks certificate

Experience with start-up and operation of biopharmaceutical manufacturing processes

Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work

Familiarity with MES, BMS, and PCS systems

Benefits

401K with company matching

Discretionary Profit Sharing

Annual Bonus Program (Sales Bonus for Sales Jobs)

Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days

Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)

HSA & FSA Programs

Well-Being and Work/Life Programs

Long-Term Incentive Program (subject to job level and performance)

Life & Disability Insurance

Concierge Service

Pet Insurance

Tuition Assistance

Employee Referral Awards

Company

Kyowa Kirin, Inc.- U.S.

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

Founded in 1949

Princeton, New Jersey, US

501-1000 employees

https://kkna.kyowakirin.com/

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)

2021 (1)