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.

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

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.)
• 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
• Ability to work in a fast-paced environment
• Effective communication, both written and oral
• Ability to present complex information to others
• Ability to 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 12 years of calibration experience in a pharmaceutical or other highly regulated industry; or
• Associate degree in Engineering or related field with 10 years of calibration experience in a pharmaceutical or other highly regulated industry; or
• Bachelor’s degree in Engineering or related field with 8 years of calibration experience in a pharmaceutical or other highly regulated industry
• Experience working in a cGMP environment
• 1-2 years of experience managing a team of technicians

Preferred Skills / Certifications

• Experience with project management methodologies
• Experience with lean manufacturing principles
• Lean Six Sigma or other process improvement certifications

Working Conditions & Physical Requirements:

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. 
• Will work in environment operating a motor vehicle or Powered Industrial Truck.
• May be required to operate a pallet jack
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time - up to 60 minutes
• Ability to sit for prolonged periods of time - up to 60 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. 

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.

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.

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 (FDBN_PNC@fujifilm.com).