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Kyowa Kirin, Inc.- U.S. · 1 day ago

Manufacturing Operator II

Sanford, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company focused on delivering novel medicines. The Manufacturing Operator II will support the start-up and execution of core manufacturing operations for rare disease therapies, ensuring compliance with safety and GMP standards while collaborating with various teams.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

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

Executes 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

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

Collaborates with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams to support compliant and efficient operations during commissioning and routine manufacturing

Assists with equipment validation and qualification activities in coordination with engineering 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 through routine cleaning and preventive maintenance in 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

Trains and mentors new team members in manufacturing processes, equipment operation, safety procedures, and company standards to support team development and consistency

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

Qualification

Biopharmaceutical manufacturingGMP complianceProcess validationEquipment commissioningLean manufacturingMES systemsTechnical writingProblem-solvingMicrosoft OfficeTeam collaborationAttention to detailAdaptability

Required

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 also preferred

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

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

Basic technical writing skills, such as reviewing or editing SOPs

Proficient in Microsoft Office applications (e.g., Word, Excel, Outlook)

Strong problem-solving and critical thinking abilities

Able to read and interpret technical documents, troubleshoot basic issues, and operate production equipment

Proficient in English, with the ability to perform basic math and statistical calculations

Results-oriented and able to navigate ambiguity

Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives

Respond promptly, take accountability, and manage tasks efficiently

Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges

Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment

Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness

Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset

Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment

Contribute positively by recognizing achievements and encouraging a healthy work-life balance

Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain

Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions

Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions

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

Exposure to upstream and/or downstream bioprocessing operations is preferred

Familiarity with MES, BMS, and PCS systems is preferred

Experience with authoring or editing SOPs is a plus

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)