Manufacturing Specialist 1, Documentation
Fujifilm•Holly Springs, NC
•Onsite
About The Position
Join a 24/7, state-of-the-art biopharmaceutical manufacturing site and play a pivotal role in ensuring every record, plan, and process is accurate, compliant, and inspection-ready. As a Manufacturing Specialist I, you’ll keep production moving reliably and safely by owning documentation, batch readiness, and day-to-day manufacturing support that enables life-changing medicines to reach patients.
Requirements
- High School Diploma/GED and 10 years of related experience; OR Associate’s degree, preferably in life sciences or engineering, with 8 years of direct experience; OR Bachelor’s degree, preferably in life sciences or engineering, with 6 years of direct experience; OR Equivalent military experience/training
- Strong CGMP manufacturing operations experience
- Understanding of operations sequence and cadence of activities
- Prior experience updating and creating manufacturing documents per schedule
- Strong verbal and written communication; able to adapt style for different audiences
- Strong time management; able to prioritize in a fast-paced, dynamic setting
- Critical thinking with strong problem-solving skills
- Team-first mindset; ability to build relationships and work effectively in a global team environment
- Comfortable working independently with general guidance and taking ownership of outcomes
Nice To Haves
- BioWorks or BTEC Capstone CGMP coursework
- Experience collaborating across global teams and with cross-functional partners
Responsibilities
- Support operational readiness initiatives and contribute to site commissioning and qualification activities
- Serve as a process subject matter expert (SME) for your area(s); support troubleshooting to maintain reliable production
- Coordinate batch planning, including process template creation and import
- Plan and manage non-batch activities such as changeover, preventive maintenance (PMs), and column packing
- Maintain accurate, current production documentation; execute timely updates, redlines, and process improvements
- Assist with inventory management; support efficient operations leveraging SAP
- Support technology transfer within the manufacturing domain
- Ensure adherence to safety policies and CGMP compliance across the manufacturing environment
- Initiate, manage, perform, or support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities
- Identify and/or drive improvement projects within drug substance manufacturing
- Assist and support internal/external inspections and audits; help ensure the area remains inspection-ready
- Perform other duties as assigned
Benefits
- Opportunities to learn new platforms and processes
- Flexibility with working hours and shift rotation may be required
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
