Calibration Technician II

Kyowa Kirin North America•Sanford, NC

3h•Onsite

About The Position

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. The Calibration Technician 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.

Requirements

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.
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.
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.
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.

Responsibilities

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.

Benefits

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 & 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