Manufacturing Specialist 1, Drug Product Process

Fujifilm • Holly Springs, NC

7d • Onsite

About The Position

Help bring life-changing medicines to patients by ensuring reliable, compliant manufacturing. As a Manufacturing Specialist I, DP, you’ll be a hands-on problem solver and process SME who keeps operations running smoothly in a 24/7 environment—driving documentation excellence, tech transfer readiness, and continuous improvement across Drug Product Finished Goods.

Requirements

• Strong verbal and written communication skills.
• Strong time management skills.
• Ability to adapt in a fast-paced environment, pivot, and adjust plans accordingly.
• Ability to think critically and demonstrate superior problem-solving skills.
• Ability to analyze and troubleshoot simple to moderate system and component-related issues.
• Ability to coordinate and facilitate effective small cross-functional teams.
• Ability to mentor and guide junior-level associates.
• Ability to effectively present information to others.
• Team-based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others.
• High School Diploma or Equivalent with 9 years of applicable industry experience OR Bachelor’s degree with 5 years of applicable industry experience OR Master’s degree with 3 years of applicable industry experience OR PhD without experience OR Equivalent Military Experience

Nice To Haves

• High degree of understanding of operations sequence and cadence of activities in a manufacturing environment.

Responsibilities

• Support operational readiness during the project phase, including site commissioning and qualification efforts.
• Troubleshoot process issues and act as a process subject matter expert (SME) for assigned area(s).
• Coordinate batch planning, including process template creation, import, and the management of Preventative Maintenance (PMs).
• Own, perform, or drive major documentation updates (including initiating new documents for new processes).
• Coordinate non-batch activities such as changeover, PMs, and Aseptic Process Simulation (APS).
• Support MSAT with technology transfer activities within manufacturing.
• Ensure manufacturing operations adhere to all compliance and safety procedures.
• Create and update Electronic Batch Records (EBRs) and Paper Batch Records.
• Manage, perform, initiate, or support change management records, investigations, Corrective and Preventive Actions (CAPAs), and Continuous Improvement (CI) activities.
• Manage projects, lead execution, and participate in projects within Drug Product Finished Goods.
• Assist and support inspections and audits to ensure compliance in the manufacturing environment.
• Assist the Manager with projects and training, as needed.
• Collaborate effectively in small, cross-functional teams; mentor and guide junior associates.
• Flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

Benefits

• Competitive compensation with potential shift differentials for 24/7 operations.
• Comprehensive health and wellness benefits.
• Retirement savings and financial wellness support.
• Paid time off, paid holidays, and flexible scheduling where business needs allow.
• Professional development, mentorship, and training opportunities.
• Inclusive, team-oriented culture with global collaboration and opportunities to grow your career.
• Recognition programs and opportunities to lead and influence process improvements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED