Associate Manager, I&C

Position Overview

The Associate Manager of Instrumentation & Controls (I&C) ensures the efficiency and operational reliability of the site instruments through an effective calibration process. This role sets the direction and manages the development of the I&C team as the site transitions from construction to operations. Additionally, this role assists with establishing efficient programs designed fit for future operations by utilizing current Good Manufacturing Practice (cGMP) / Good Laboratory Practice (GLP) knowledge, work scheduling, instrument calibration, repair, and troubleshooting. This role also provides day-to-day oversight and development of the I&C team.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

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:

Job Description

What You'll Do

• Executes the calibration strategy to ensure the safe and reliable operation of the site's equipment and systems in alignment with site objectives
• Leads and develops a team of I&C technicians across all aspects of personnel management
• Develops and maintains calibration operating guidelines, work instructions, and standard operating procedures (SOPs)
• Designs and implements reliability driven calibrations and monitoring plans and practice
• Analyzes calibration data to identify trends and take corrective and preventive action (CAPA), as needed
• Oversees 3rd party service providers and ensures adherence to I&C standards and procedures
• Adheres to and enforces compliance with all Quality, Environmental, Health & Safety (EHS) and other applicable regulatory requirements (e.g., Food & Drug Administration (FDA), Occupational Safety and Health Administration (OSHA) regulations, and cGMP)
• Identifies opportunities for process or system improvements and implements the respective strategies
• Ensures all calibration activities are completed in a cost-effective manner
• Collaborates with other departments (e.g., Utility Operations, Spare Parts, Manufacturing, Quality Control, Engineering) to ensure I&C activities support the overall goals of the site
• Supports the design, installation, commissioning, qualification, and training activities for I&C
• Participates in site visits to FDB goal locations for knowledge sharing and learning of best practices
• Serves as a coach and technical mentor for technicians to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent
• Addresses employee questions, concerns, and partners with HR, as needed for resolution
• Evaluates direct reports performance and address gaps accordingly
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports, etc.)
• Performs other duties, as assigned

Knowledge & Skills

• Knowledge of technical documents (e.g., User Requirement Specification (URS), Site Acceptance Test (SAT), Factory Acceptance Test (FAT), Commissioning and Validation protocols)
• Strong knowledge of computerized maintenance management system (CMMS), such as Infor
• Ability to interpret cGMP regulations and their application to calibration activities
• Leadership skills and willingness to mentor technicians
• Ability to lead a team and manage multiple projects simultaneously
• Effective communication, both written and oral
• Ability to present complex information to others
• Ability to work in a fast-paced environment, adapt and be flexible with schedule to effectively communicate and manage teams on shift
• Flexibility to provide on-call support to 24/7 calibration teams
• Active passport
• Travel required, 10%

Required Skills

• High School Diploma/GED with 6+ years of calibration experience in a pharmaceutical or other highly regulated industry; or
• Associate degree in engineering or related field with 4+ years of calibration experience in a pharmaceutical or other highly regulated industry; or
• Bachelor's degree in engineering or related field with 2+ years of calibration experience in a pharmaceutical or other highly regulated industry
• Experience mentoring and leading people
• Prior experience working in a cGMP environment
• Experience working in a changing, project driven organization

Preferred Skills

• Experience with regulatory inspections, investigations, and change management
• Experience in and with leading others in a pharmaceutical / biological manufacturing operations
• Experience with project management methodologies and lean manufacturing principles
• Lean Six Sigma or other process improvement certifications

Working Conditions & Physical Requirements:

Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes May be required to operate a pallet jack
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs., more with assistance
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes

Benefits

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!

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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 ([email protected]).