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 commercialization.

In 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 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.

This role reports to the Supervisor, CMMS and Calibration Services

• 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…