Manufacturing Coordinator

FUJIFILM Electronic Materials (Europe) N.V.; North Carolina; On-site; USD 70,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a Manufacturing Coordinator to ensure equipment and process items are ready for processing, and to coordinate equipment changeovers and related changeover activities, including PRs and cleaning validation data. The role requires coordinating with maintenance, QA, QC, metrology, and MT&S, and contributing to TPM and Lean Six Sigma initiatives.

The position emphasizes cross-functional collaboration to prevent schedule conflicts during campaigns

Qualifications

• BS/BA (science preferred) with 3+ years in a cGMP pharmaceutical/manufacturing environment OR AA (science preferred) with 5+ years in a cGMP pharmaceutical/manufacturing environment.

Responsibilities

• Coordinate operations for equipment changeover, equipment sample requirements, and equipment release.
• Coordinate the ordering of swab solution and deliver it to the manufacturing floor, coordinating with maintenance on changeover schedules and cleaning validation sampling.
• Review schedule to identify conflicts with equipment or areas during client campaigns and escalate findings to senior management and planning.
• Coordinate with manufacturing and MT&S on equipment and supplies for new and existing processing, including items like carboys, cylinders, hoses, and other equipment.
• Coordinate with metrology for equipment calibrations.
• Work with QA and QC to complete and release equipment changeovers and ensure PRs are closed before due date; gather information if OOTs occur.
• Participate in TPM, 5S, Lean Six Sigma, Change Control, changeover, safety, quality projects and practices.
• Identify and implement cost-saving initiatives for hoses, supplies, and equipment.

Education

BS/BA (science preferred)

AA (science preferred)

Job description

Position Overview

The Manufacturing Coordinator is responsible for activities associated with ensuring manufacturing has equipment and process items available for processing right the first time. The Manufacturing Coordinator is also responsible for coordinating of equipment changeovers, and all activities associated with the changeovers such as PRs, providing sample information from cleaning validation to the process floor.

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:

• Coordinate operations for equipment changeover, equipment sample requirements, and equipment release.
• Coordinate the ordering of swab solution and getting the solution to the manufacturing floor. This includes working the maintenance group with equipment changeover schedule and cleaning validation on cleaning sampling that are required.
• Review schedule to identify any possible conflicts with equipment or areas during different client campaigns and elevate any finding to senior manufacturing management and manufacturing planning.
• Coordinate with manufacturing and MT&S on equipment and supplies needed for new processing and existing processing. This includes ordering items such as carboys, cylinders, hoses, and any other equipment or supplies that may be needed.
• Coordinating with metrology of equipment calibrations.
• Work with QA and QC to complete and release equipment changeovers on equipment. This includes ensuring that all PRs associated with these activities are closed prior to due date. If OOTs are observed during equipment calibrations gather information on what is needed by QA.
• Participates in routine practices and team projects relating to TPM, 5S, Lean Six Sigma, Change Control, change over, Safety, Quality, etc.
• Identify and implement cost‑saving initiatives hoses, supplies, and equipment and other readiness related expenses.

Required Skills/Education:

• BS/BA (science preferred) and 3+ years of experience in a cGMP (pharmaceutical/manufacturing environment OR AA (science preferred) and 5+ years of experience in a cGMP (pharmaceutical/manufacturing) environment

Working Conditions & Physical Requirements:

• Ability to discern audible cues
• Will work in environment which may necessitate respiratory protection.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time, up to 240 minutes
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to operate machinery and/or power tools.
• Ability to sit for prolonged periods of time, up to 240 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• 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.
• Will work in heights greater than 4 feet.

Our programs are designed to focus on maintainingand enhancing all pillars of health with arobustbenefitspackageincluding medical, dental, vision and prescription drug coverage with the option of a Health Savings Account withcompany contributions. In addition, we offer an industry leading401(k) savings plan, insurance coverage, employeeassistanceprograms 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!

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 ([e-mail]).