About this role
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.
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
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 place. 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.
Other facts
About Fujifilm
FUJIFILM Electronic Materials develops and manages chemical formulations that power the most critical processes of semiconductor technology. We are a diverse, global supplier that delivers tailored support where our customers need us most. The spirit of partnership drives everything we do — our commitment to the continued success and innovation of our customers is our primary focus. Through state-of-the-art systems, leading-edge technologies, and a commitment to the continuous development of environmentally friendly processes, FUJIFILM Electronic Materials is:
DEDICATED — to the success of our customers and team
CURIOUS — with a genuine interest in finding new ways to innovate
DRIVEN — motivated to push the boundaries of possibility
COLLABORATIVE — committed to working jointly to develop the best solutions
Headquartered in Yokohama, Japan, FUJIFILM Electronic Materials has 11 regional offices globally. As proud members of the FUJIFILM Group, we are one of the leading and most trusted producers of the chemical formulations that enable our partners to progress semiconductor technology to the next node and beyond. Our assured, stable supply is proven through our state-of-the-art quality system. Leveraging leading-edge technologies, our formulations help to power cell phones, computers, medical devices, cars, refrigerators and other goods essential to human life.
The engineers, scientists, manufacturing staff and other professionals who commit their skills and intellect to FUJIFILM Electronic Materials strive to make a difference in their jobs and in the world. Our organization offers the opportunity to pursue challenging and meaningful work in an environment that supports growth. With an internal culture that prioritizes teamwork, open communication and shared success, FUJIFILM Electronic Materials inspires both personal and customer advancement.
What you'll do
- The manufacturing associate will operate the filling line and support various manufacturing processes, including training others and assisting in scheduling daily activities. They will also participate in project phases, contributing to documentation and operational readiness.
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