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Kyowa Kirin, Inc.- U.S. · 2 months ago

Senior Calibration Technician

Sanford, NC

Full-time

Hybrid

Mid, Senior Level

$35/hr - $48/hr

3+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The Senior Calibration Technician is responsible for performing, coordinating, and documenting the calibration, maintenance, and repair of instrumentation and equipment in a regulated biopharmaceutical environment, ensuring compliance with GxP and company quality standards while supporting production and laboratory operations.

Pharmaceuticals

H1B Sponsor Likely

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 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

Conduct root cause analysis and implement corrective and preventive actions (CAPA) for calibration-related deviations

Identify inefficiencies in calibration and maintenance processes and implement improvements that enhance accuracy, consistency, and productivity

Collaborate with process engineers, manufacturing, quality assurance, and facilities teams to resolve technical issues and align on operational priorities

Train and guide team members and contractors on calibration procedures, equipment handling, and documentation standards to ensure consistency and compliance

Lead technical investigations using structured, data-driven approaches to resolve instrumentation failures and recurring issues

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

Qualification

CGMP-compliant calibrationCMMS platformsCalibration proceduresRoot cause analysisTechnical guidanceContinuous improvementInterpersonal skillsAttention to detailOrganizational skillsCollaboration

Required

High school diploma or equivalent, plus 4–6 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 3–5 years of demonstrated hands-on experience performing cGMP-compliant calibration in manufacturing, laboratory, or facility environments

Alternatively, demonstrated minimum of 4–6 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

Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE

Must be able to perform the physical requirements of the role, including occasionally lifting to 50 lbs, with or without reasonable accommodation

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

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)