Calibration Technician II

Kyowa Kirin•Sanford, NJ

2d•Onsite

About The Position

The Calibration Technician II performs, coordinates, and documents calibration, maintenance, and repair of instrumentation and equipment in a regulated biopharmaceutical environment. The role supports production, laboratory, and facilities operations while ensuring compliance with GxP and company quality standards. It contributes to continuous improvement and team efficiency, working collaboratively and with accountability in support of business goals and patient-focused work. This is an on-site position at the Sanford, North Carolina facility. The standard schedule is Monday through Friday, 8:00 A.M. to 4:30 P.M., though the schedule may transition to a 2-2-3 format that includes every other weekend. Nontraditional shifts and on-call availability may be required to support business needs. The role involves up to 5% domestic travel and work in a regulated manufacturing environment, including construction/start-up phases.

Requirements

High school diploma or equivalent and 1–3 years of relevant calibration and/or instrumentation experience; alternatively, an associate or bachelor’s degree in a related field and 1–2 years of relevant experience.
At least 1–3 years of hands-on experience performing cGMP-compliant calibration in manufacturing, laboratory, or facility environments; alternatively, at least 2–4 years of calibration experience in a highly regulated industry if direct GMP experience is unavailable.
Proficiency with CMMS platforms such as D365 EAM, SAP PM, Maximo, or similar systems.
Ability to collaborate effectively with internal teams and external clients while supporting customer service and operations.
Strong communication and organizational skills for clear information sharing and cross-functional workflow management.
Meticulous attention to detail and commitment to accurate, complete, audit-ready records and data integrity.
Ability to work on-site in a regulated manufacturing environment and use required PPE.
Ability to safely lift up to 50 lbs unassisted and perform tasks involving physical activity.
Ability to work nontraditional shifts as required and provide on-call support for urgent operational needs.

Responsibilities

Perform scheduled calibrations, adjustments, and preventive maintenance on laboratory, process, and facility instrumentation.
Diagnose and resolve instrumentation and equipment issues, escalating unresolved, critical, or systemic issues to the Supervisor, CMMS and Calibration Services.
Develop and execute calibration procedures and protocols in compliance with GMP, ISO, and company standards, and recommend updates based on technical findings and regulatory changes.
Document calibration activities, maintenance, and repairs in CMMS or Calibration Management Systems to ensure traceability and audit readiness.
Prepare documentation for inspections and audits, and identify and correct compliance-record gaps.
Assist with root cause analysis and implement corrective and preventive actions for calibration-related deviations.
Collaborate with process engineers, manufacturing, quality assurance, and facilities teams to resolve technical issues and align operational priorities.
Communicate updates, findings, and recommendations clearly and professionally to internal stakeholders.
Prioritize and manage multiple tasks and projects independently while meeting deadlines and quality expectations.
Promote safety, inclusion, and continuous improvement in calibration and maintenance activities.

Benefits

401(k) with company matching
Annual bonus program
Generous paid time off and holiday schedule, including summer and winter shutdowns, sick days, and volunteer days
Medical, dental, prescription drug, and vision healthcare benefits
HSA and FSA programs
Well-being and work/life programs
Long-term incentive program, subject to job level and performance
Life and disability insurance
Concierge service
Pet insurance
Tuition assistance
Employee referral awards