Supervisor, CMMS and Calibration Services

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.

As the Computerized Maintenance Management System (CMMS) Supervisor you will play a critical role in leading the utilization and effectiveness of the Microsoft Dynamics 365 (D365) Enterprise Asset Management (EAM) system. You will serve as a key link between maintenance technicians internal customers and leadership. Your responsibilities will include managing the CMMS platform supervising and mentoring team members analyzing data and ensuring data integrity. You will also contribute to the overall efficiency and reliability of the maintenance program.

You will be responsible for ensuring that all GMP and non-GMP equipment calibrations remain compliant with applicable regulatory and business requirements to support operations at the Kyowa Kirin Sanford site. To succeed in this role you must be detail-oriented organized and possess a strong understanding of calibration best practices planning execution and instrumentation.

Your key responsibilities will include:
Establishing initial calibration requirements
Building and managing the site calibration program
Onboarding and leading contracted services
Developing and training the calibration team
Reviewing calibration documentation within D365 EAM
Supporting compliance investigation
Ensuring Data Integrity
Training all users of the system
Ensuring the reliability of assets and full compliance with all regulations and operating requirements

As a people leader you will embody compassionate people-centric leadership to guide and support our team. You will collaborate closely with others fostering a collaborative inclusive and supportive environment while driving team development. Your work will reflect the organizations values and integrity in all your actions. Utilizing situational leadership and emotional intelligence you will align diverse viewpoints manage stakeholders and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally you will help teams navigate through change and uncertainty with resilience and clarity enabling them to adapt to fast-evolving rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.

The role reports into the Senior Manager Maintenance and Facility Services

Technical
Ensure timely completion and accurate maintenance of asset data in the CMMS including asset location hierarchies and security profiles.
Lead and organize the spare parts program by ensuring parts are correctly assigned to appropriate assets properly maintained stored under suitable conditions and kitted efficiently to support maintenance activities.
Analyze CMMS data to identify trends recommend improvements and enhance the overall efficiency of the maintenance program.
Generate and interpret timely relevant reports on work orders equipment history and key performance indicators (KPIs) to support data-driven management decisions.
Provide timely CMMS training to all system users.
Create clear user-friendly materials to help users complete tasks and submit work requests efficiently.
Collaborate proactively with procurement inventory teams and external vendors to execute specialized tasks and ensure alignment across functions.
Communicate effectively with cross-functional departments and stakeholders to drive process improvements and ensure timely coordination and alignment.
Lead the site Metrology program by managing calibration technicians and third-party vendors ensuring full compliance with all applicable regulatory requirements.
Develop and maintain the Metrology training program by establishing clear goals objectives and performance benchmarks to evaluate staff effectiveness.
Manage vendors and contractors supporting both ongoing operations and future projects ensuring alignment with project goals and operational standards.
Provide hands-on leadership and support to ensure the reliability of assets and full compliance with all regulations and operating requirements

Leadership
Results-Oriented: Lead teams by setting clear measurable goals and ensuring accountability for achieving key objectives. Align resources effectively remove obstacles and maintain focus on delivering high-quality results within set timelines.
Empathetic Communication: Listen carefully give helpful feedback and handle conflicts with care.
Team Development: Mentor and guide team members create growth plans support ongoing learning and develop the team with a patient-focused mindset.
Inclusive Leadership: Build a diverse respectful environment where everyone feels valued and supported.
Supportive Environment: Encourage a positive workplace celebrate achievements and promote work-life balance.
Collaboration: Lead by example promote teamwork and respect and ensure your actions reflect the organizations values.
Emotional Intelligence: Manage emotions thoughtfully make empathetic decisions with a patient-focused mindset and stay calm under pressure.
Change Management: Help teams navigate change with clear communication and flexibility.
Situational Leadership: Adapt your leadership style to meet the needs of the team offering guidance or independence as needed while keeping patient outcomes in mind.
Stakeholder Management and Alignment Building: Work with different people to build alignment guide discussions toward common goals and ensure decisions are aligned with a patient-focused mindset.

Subordinates: CMMS Coordinator CMMS Administrator and Calibration Technician

Education
High school diploma or equivalent required.
Associates or Bachelors degree in Instrumentation and Controls or a related technical field preferred.

Experience
Minimum of 25 years of experience working within a CMMS platform.
Minimum of 25 years of experience in calibration.
Minimum of 1-3 years of GMP Pharmaceutical experience.
Previous lead or supervisory experience or experience as a maintenance planner or CMMS administrator required.
Previous calibration experience within the military is a plus.
CMMS implementation or data migration experience is a plus.

Technical Skills
Strong technical knowledge of mechanical systems calibration practices utilities and facility trades.
Experience with CMMS platforms such as D365 EAM SAP PM Maximo or other similar systems.
Proficient in spare parts management including allocation tracking and inventory control.
Excellent organizational planning analytical and problem-solving skills.
Ability to generate reports and interpret data within the CMMS to support decision-making.
Strong collaboration skills with internal teams and external clients to promote excellence in customer service.
Experience with CMMS implementation or data migration is a plus.
Ability to import export and create templates for data management within CMMS platforms is a plus.
Solid understanding of GMP FDA regulations and cleanroom operations.
Skilled in troubleshooting and continuous improvement with a strong focus on operational efficiency.

Non-Technical Skills
Results-oriented and able to navigate ambiguity you set clear outcomes track progress follow through on commitments and ensure your 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.

Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford NC.

Work is 100% on-site. This is not a hybrid or remote role.

Requires up to 10% domestic and limited international travel.

The anticipated salary for this position will be $102900 to $134300. 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 Incentives
• 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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