Manufacturing Specialist 1, Drug Product

Fujifilm • Holly Springs, NC

96d

About The Position

The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

Requirements

• High School Diploma or Equivalent with 12 years of applicable industry experience
• Bachelor's degree with 8 years of applicable industry experience
• Master's degree with 6 years of applicable industry experience
• PhD with 4 years of applicable industry experience
• Equivalent Military Experience

Nice To Haves

• High degree of understanding of operations sequence and cadence of activities in a manufacturing environment
• Bio Works or BTEC Capstone cGMP coursework preferred

Responsibilities

• During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts
• Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
• Coordinates Batch Planning including process template creation and import and management of Preventative Maintenance (PMs)
• Owns, performs, or drives documentation major documentation updates (i.e. Initiates new documents for new processes)
• Coordinates non-batch activities (e.g., Changeover, PMs, Aseptic Process Simulation [APS])
• Supports the MSAT group with tech transfer within manufacturing
• Ensures compliance and safety procedures are followed in manufacturing environment
• Create and updates Electronic Batch Records (EBRs) and Paper Batch Records
• Manages, performs, initiates, or supports change management records, investigations, Corrective and Preventive Actions (CAPAs) and Continuous Improvement (CI) activities
• Manages projects, leads execution, and participates in projects within Drug Product Finished Goods
• Assists and supports inspections and audits, providing support to ensure compliance within the manufacturing environment
• Assists Manager with projects and training, as needed
• Other duties, as needed

What This Job Offers

• Industry: Machinery Manufacturing