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Kyowa Kirin, Inc.- U.S. · 1 day ago

Manufacturing Operator III

Sanford, NC

Full-time

Onsite

Entry, Mid Level

$40/hr - $42/hr

2+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company focused on delivering novel therapies for rare diseases. The Manufacturing Operator III will support manufacturing operations at a biopharmaceutical site, executing complex processes and ensuring compliance with safety and quality standards while collaborating with cross-functional teams.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Serve as a role model for safety and GMP compliance

Execute complex upstream and downstream processes in a regulated environment

Participates in equipment commissioning, process validation, and automation implementation

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

Support troubleshooting and continuous improvement initiatives

Proactively identify, escalate, and respond to deviations, equipment issues, or process anomalies to ensure product quality and operational continuity

Train and mentor other manufacturing associates to build team capability

Contribute to the development of 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 systems, inoculum preparation, chromatography skids, and UF/DF skids via PCS and MES systems

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

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

Takes immediate action when deviations, equipment malfunctions, or unexpected results occur, including stopping the process if necessary to prevent impact to product quality or safety

Escalates all actual or perceived non-compliance events, safety concerns, or process deviations promptly and appropriately, ensuring timely resolution and documentation

Collaborates with Process Engineering, Automation, CQV, Quality, Operational Excellence (OPEX), and Warehouse teams to ensure compliant and efficient operations during commissioning and routine manufacturing

Contributes to the development of standard operating procedures (SOPs) and facilitates equipment validation and qualification in collaboration with engineering teams

Identifies and implements process improvements to optimize manufacturing operations. Leads or contributes to initiatives that streamline workflows, eliminate waste, and enhance productivity

Demonstrates working knowledge of enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS

Leads on-the-floor troubleshooting and resolution of equipment, automation, and process-related issues. Supports CAPA documentation and tracking

Maintains cleanliness and organization of the manufacturing area by performing routine cleaning and preventive maintenance in compliance with GMP and safety standards

Applies 5S, standard work, and Kanban principles to manage the shop floor. Coordinates with Warehouse and Maintenance teams to ensure availability of materials, supplies, and equipment for uninterrupted production

Trains and mentors new team members in manufacturing processes, equipment operation, safety procedures, and company standards to ensure team competency and adherence to best practices

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

Qualification

Biopharmaceutical manufacturingGMP complianceProcess validationEquipment commissioningLean manufacturingTechnical writingContinuous improvementEnglish proficiencyProblem-solving skillsInterpersonal skillsOrganizational skillsCollaboration

Required

Bachelor's degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) and at least 2 years of relevant experience in biopharmaceutical manufacturing

Associate degree in a technical field and at least 4 years of relevant experience in biopharmaceutical manufacturing

High school diploma or equivalent and at least 6 years of relevant experience in biopharmaceutical manufacturing

Hands-on experience with key unit operations including solution preparation, upstream and/or downstream processing, inoculation, and weigh & dispense activities

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

Proficient in Microsoft Office applications

Strong problem-solving and critical thinking skills

Skilled in reading and interpreting technical documents, troubleshooting issues, and operating 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

This position is based on-site in Sanford, NC

During the start-up phase, this role may require up to three months of training at our Japan manufacturing site, to be completed within the next two years

Preferred

Experience with start-up and operation of biopharmaceutical manufacturing processes is strongly preferred

Experience in technical writing; ability to author and edit SOPs is a plus

Working knowledge of MES, BMS, and PCS systems 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 Incentives

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)