Senior Calibration Technician

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 North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

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. Demonstrating advanced expertise this role ensures compliance with GxP and company quality standards while supporting production laboratory and facilities operations. The Senior Technician leads complex calibration projects provides technical guidance to peers introduces best practices and actively contributes 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 organizations 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.

This role reports to the Supervisor CMMS and Calibration Services

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 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.

Individual contributor with the opportunity to potentially lead or coordinate task teams.

Education
High school diploma or equivalent plus 46 years of relevant experience in calibration and/or instrumentation.
Associate or bachelors degree in a related field (such as engineering technology instrumentation or life sciences) plus 12 years of relevant experience in calibration and/or instrumentation.

Experience
Minimum of 35 years of demonstrated hands-on experience performing cGMP-compliant calibration in manufacturing laboratory or facility environments.
Alternatively demonstrated minimum of 46 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.

Non-Technical Skills
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. 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.

Requires up to 5% domestic travel based on business need.
This position is designated as essential to site operations as such the employee may be required to report to the facility or remain on-site during certain operational or emergency situations to ensure business continuity.
On-call availability may be required to support urgent operational needs.
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.

The anticipated salary for this position will be $35 to $48 per/hour. 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
• 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

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.

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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.

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