Manager, Metrology

FUJIFILM Biotechnologies; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401(k) plan

Paid vacation

Sick time

Company holidays

Wellness incentives

Job summary

FUJIFILM Biotechnologies seeks a Metrology Manager to lead the Metrology team, ensuring calibration and instrument reliability across utilities and equipment. You will manage 24/7 troubleshooting, calibrations, and repairs, while aligning goals with business needs and stakeholders.

Responsibilities include developing staff, driving KPI performance, and maintaining GEP for instruments and related Work Orders, with collaboration across Engineering, QA, and Manufacturing.

Qualifications

• B.S. Degree in Engineering or related technical field with 10+ years of relevant experience, or M.S. with 6+ years relevant experience.
• Working knowledge of validation principles to support utility systems qualification.
• Proven track record of staff management with 5+ years in a leadership role.
• Familiarity with Quality Management Systems.
• Deep knowledge of bio-pharmaceutical Clean Utilities and site operations.

Responsibilities

• Lead the Metrology team to maintain Process Measurement and Control Instrumentation per standards.
• Provide 24/7 emergency coverage for instrument troubleshooting and repair.
• Oversee scheduling of instrument repairs and calibrations with staff or vendors.
• Develop staff and organizational capabilities to meet KPIs and goals.
• Ensure system ownership and Quality System documentation including Change Controls and CAPAs.

Skills

Engineering management

Project leadership

Validation principles

Quality systems

Bio-pharma utilities

Staff development

Communication skills

Regulatory awareness

Education

Bachelor's in Engineering or related field

MS in engineering or related field

Job description

The Metrology Manager manages the Metrology team for calibrations of utilities and equipment for the site. The position ensures goals and objectives for the team are well established and in line with business needs and stakeholder expectations while overseeing the team’s daily operations including pre/post calibrations, instrument setup and configuration, and 24/7 site instrument troubleshooting support.
The Metrology Manager serves as the System Owner for instrument calibration standards. In addition, the role oversees the electronic calibration management system and the initiation of any Out of Tolerance (OOT) reports in the quality system. The Metrology Manager will lead the Metrology team to recruit, train, and guide resources to ensure the performance and productivity of the group.

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.
From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.
Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do:

• Lead the Metrology team to ensure that Process Measurement and Control Instrumentation is maintained in accordance with FDBU standards and specifications.
• Ensures existing instrumentation is turned over in good working condition providing 24/7 emergency coverage for the troubleshooting and repair of plantwide Process Measurement and Control Instrumentation.
• Oversee the scheduling of instrument repairs and calibrations through on-site staff or approved vendors.
• Ensure effective team communication and tracking of open Work Orders and operational issues.
• Provide technical leadership and coaching to members of the team and broader site personnel when required.
• Develop organizational capabilities to ensure continued staff development.
• Develop functional goals, drive, and monitor performance against goals and KPIs.
• Manage preventive maintenance assignments based on risk and reliability management.
• Manage and maintain Good Engineering Practice (GEP) for instruments and associated Work Orders.
• Manage required system owner Quality System documents including Change Controls, Deviations, Corrective and/or Preventive Actions.
• Collaborate with Engineering, MTS, QA, and Manufacturing functions to document equipment specifications and user requirements.
• Provide technical support in case of instrument-related process deviations in root cause investigation and implementation of Corrective and/or Preventive Actions.
• Provide input to the Site Validation Master Plans as needed for Process Measurement and Control Instrumentation.
• Develop and maintain task-related Standard Operating Procedures and Work Instructions.
• Provide client and regulatory inspection support.

Required Skills/Education

• B.S. Degree in Engineering or related technical degree with 10+ years relevant experience OR M.S. with 6+ years relevant experience. Including 5+ years of direct process engineering or manufacturing engineering experience.
• Working knowledge of validation principles to provide support for utility systems qualification.
• Proven track record of staff management, capable of developing people and teams with 5+ years of management experience.
• Familiarity with Quality Management Systems.
• Sound industry knowledge, project proficiency, and autonomy are expected.
• Must possess in-depth knowledge of bio-pharmaceutical Clean Utilities.
• Ability to organize and present technical overviews to staff, cross-functional departments, and site management.
• Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels.
• Maintains effective relationships across functional units gaining their trust and respect.
• Puts accomplishing the goals of the team ahead of accomplishing individual goals.
• Openly shares expertise with co-workers to help strengthen general knowledge and skills.
• Solicits input/feedback from others beyond role or departmental boundaries as a developmental opportunity.
• Approaches situations objectively and is receptive to various viewpoints.
• Exhibits professionalism and sets an example for others to follow.
• Self-starter and detail-oriented.
• Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve.
• Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action.
• Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnel.
• Ability to lead teams with and without a direct reporting structure while demonstrating influential leadership skills.

Desired Skills

• Previous electronics or electrical experience.
• Prior apprenticeship, technical college, or military experience is a plus.

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).