FUJIFILM is looking for a Manufacturing Specialist 1, DP to perform manufacturing support activities to ensure compliant and reliable production.
Requirements
- 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
- Create and updates Electronic Batch Records (EBRs) and Paper Batch Records
Other
- May require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility
- Ensures compliance and safety procedures are followed in manufacturing environment
- 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
