Manufacturing Coordinator

Fujifilm • Morrisville, NC

6d • Onsite

About The Position

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.
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

Requirements

• 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

Responsibilities

• 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 escalate 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 ensuing 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.

Benefits

• medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions
• an industry leading 401(k) savings plan
• insurance coverage
• employee assistance programs
• various wellness incentives
• paid vacation time
• sick time
• company holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree