Calibration Technician II

Job title: Calibration Technician II

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.

Summary:

The Calibration Technician II is responsible for performing, coordinating, and documenting the calibration, maintenance, and repair of instrumentation and equipment in a regulated biopharmaceutical environment. This role ensures compliance with GxP and company quality standards while supporting production, laboratory, and facilities operations. The calibration technician will actively contribute to continuous improvement and team efficiency.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

Essential Functions:

Technical Skills, Knowledge, and Experience

• Perform scheduled calibrations, adjustments, and preventive maintenance on laboratory, process, and facility instrumentation including pressure, temperature, flow, pH, conductivity, balances, HPLC, incubators, autoclaves, and cleanroom monitoring systems.
• Diagnose and resolve (with some assistance) complex instrumentation and equipment issues independently to minimize downtime and maintain operational continuity.
• Escalate unresolved, critical, or systemic calibration and instrumentation issues to the Supervisor, CMMS and Calibration Services, providing clear documentation and recommended actions.
• Develop and execute calibration procedures and protocols in compliance with GMP, ISO, and company standards; recommend updates based on technical findings and regulatory changes.
• Document all calibration activities, maintenance, and repairs accurately in CMMS/Calibration Management Systems to ensure traceability and audit readiness.
• Prepare documentation that meets GMP, FDA, and internal quality standards for inspections and audits; identify and correct gaps in compliance records.
• Assist in root cause analysis and implement corrective and preventive actions (CAPA) for calibration-related deviations.
• Collaborate with process engineers, manufacturing, quality assurance, and facilities teams to resolve technical issues and align on operational priorities.
• Communicate clearly and professionally with internal stakeholders to share updates, findings, and recommendations.
• Prioritize and manage multiple tasks and projects independently in a fast-paced, regulated environment while meeting deadlines and quality expectations.
• Promote a culture of safety, inclusion, and continuous improvement across calibration and maintenance activities.

Requirements

Education

• • High school diploma or equivalent, plus 1-3 years of relevant experience in calibration and/or instrumentation.
• • Associate or bachelor’s degree in a related field (such as engineering technology, instrumentation, or life sciences), plus 1–2 years of relevant experience in calibration and/or instrumentation.

Experience

• • Minimum of 1-3 years of demonstrated hands-on experience performing cGMP-compliant calibration in manufacturing, laboratory, or facility environments.

• • Alternatively, demonstrated minimum of 2-4 years of calibration experience within a highly regulated industry (such as pharmaceuticals, medical devices, or aerospace) if direct GMP experience is not available.

• Technical Skills

• • Proficient in using CMMS platforms such as D365 EAM, SAP PM, Maximo, or similar systems to manage calibration schedules, documentation, and asset history.

• • Demonstrated ability to collaborate effectively with internal teams and external clients, consistently promoting excellence in customer service and operational support.

• • Exceptional communication and organizational skills, enabling clear information sharing and efficient workflow management across cross-functional teams.

• • Meticulous attention to detail and a strong commitment to data integrity, ensuring all calibration records and documentation are accurate, complete, and audit-ready.

Physical Demands:

• Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.

Working Conditions:

• • Requires up to 5% domestic travel, based on business need.

• • Standard work schedule is Monday through Friday, 8:00 A.M. to 4:30 P.M.

• • Position may transition to a 2-2-3 (EOW-Every Other Weekend) schedule format as the business needs change. As required, incumbent must be able to work nontraditional shifts to meet business needs.

• • This position is considered essential to the facility.

• • On-call availability may be required to support urgent operational needs.

• • Must be able to safely lift up to 50 lbs unassisted and perform tasks involving physical activity.

• • Regular exposure to machinery, noise, and physical hazards in a manufacturing environment; appropriate personal protective equipment (PPE) is provided and required at all times.

• • Work is performed 100% on-site at the Sanford, NC facility; remote or hybrid work is not available for this role.

• The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

• KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

• It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

• When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

• Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us.

• Recruitment & Staffing Agencies

• Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

• LI-TT1 Sanford North Carolina OnSite