Manufacturing Associate 4, Visual Inspection (2nd Shift 3pm to 11:30pm)

FUJIFILM; United States; Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

FUJIFILM Biotechnologies in North Carolina seeks a Manufacturing Associate for drug product filling and related processes. The role supports project activities, training, and daily scheduling on a 24/7 facility with a second shift schedule.

The position requires GMP knowledge, experience in manufacturing, and the ability to work rotating shifts, including weekends and nights. Training and documentation duties are emphasized.

Qualifications

• High School Diploma or GED required.
• Associate’s or Bachelor’s degree with direct cGMP manufacturing experience preferred.
• Experience with GMP documentation and procedures is desired.
• Experience operating production equipment and training coworkers is valuable.

Responsabilités

• Lead, execute and document manufacturing processing steps and related activities.
• Operate the drug product filling line and support manufacturing processes.
• Validate protocols per cGMP SOPs and maintain compliant GMP documents.
• Establish processes and training to develop trainers among coworkers.

Connaissances

GMP knowledge

Training & coaching

Documentation

Process monitoring

Formation

High School Diploma or GED

Associate’s Degree + 4 years direct experience in cGMP

BA/BS + 2 years direct experience in cGMP

Equivalent Military training or experience

Description du poste

Position Overview

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.

This position has a second shift schedule.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

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

During the project phase

• Participate and support testing activities, such as FAT, PQ etc. as well as other related activities
• Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions
• Contribute to the preparation for operational readiness related to bulk drug product manufacturing
• Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support
• Travel up to 0-25% (international or domestic) may be required during the project phase

In operations

• Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control
• Perform operations of the Drug product filling line
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Own the establishment of processes and trainings to become a trainer for coworkers
• Maintain compliance of GMP documents and ensure own training level is complaint and maintained
• Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed
• This role requires shift work (weekend and potential for nights)
• Perform other duties as assigned

Basic Requirements

• High School Diploma or GED
• 6+ years of direct experience in a manufacturing environment

Preferred Requirements

• Associate’s Degree + 4 years of direct experience in a cGMP manufacturing environment OR
• BA/BS + 2 years of direct experience in a cGMP manufacturing environment
• Equivalent Military training or experience
• Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)
• Understanding of manufacturing run cadence and order of shift activities
• Knowledge of cGMP, safety and operational procedures
• A high degree of knowledge and expertise of the operation of specific production equipment

Working Conditions & Physical Requirements

• Be exposed to an environment that may necessitate respiratory protection
• Be exposed to noisy environments
• Have a normal range of vision
• Climb ladders and stairs of various heights
• Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours
• Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required
• May be required to lift up to 50 pounds on occasion

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]).