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 anticipated salary for this position will be $30.00/hr to $41.00/hr. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

401K with company matching

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 & F