Manufacturing Coordinator

Fujifilm • Research Triangle Park, NC

5d • 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. FUJIFILM Biotechnologies is a leader in advancing tomorrow's medicines, working with innovative biopharmaceutical companies. The company offers a collaborative, creative, and purpose-driven environment where employees can make a direct impact on patients' lives. Located in the biotech hub of North Carolina, FUJIFILM is globally headquartered in Tokyo and operates across healthcare, electronics, business innovation, and imaging segments, guided by its Group Purpose of “giving our world more smiles.”

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
• Ability to discern audible cues
• 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 wrists, 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.

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.
• Work with the maintenance group on 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, including ordering items such as carboys, cylinders, hoses, and any other equipment or supplies that may be needed.
• Coordinate with metrology of equipment calibrations.
• Work with QA and QC to complete and release equipment changeovers on equipment, 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 for hoses, supplies, 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.
• 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