Associate Manager, Instrumentation & Controls

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

Executes the calibration strategy to ensure the safe and reliable operation of the sites 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
Bachelors 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 maintainingand enhancing all pillars of health with arobust benefits package including medical dental vision and prescription drug coverage with the option of a Health Savings Account with company addition we offer an industry leading401(k) savings plan insurance coverage employee assistanceprograms and various wellness incentives. We support life-work balance withpaid 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 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 committedto 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 ().

Required Experience:

Manager

Position OverviewThe 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 constr...