The business problem FUJIFILM is looking to solve is to support start up and operational activities for the site by leading a shift team and being responsible for the manufacturing process and facility which will eventually operate 24/7 model.
Requirements
- Experience with electronic batch records
- Root cause analysis
- Technical writing
- Initiation of investigations
- Experience working in facility start-up environment
- Experience working in a pharmaceutical manufacturing environment
- Lean Six Sigma or similar certification
Responsibilities
- Provides on the floor leadership for a shift team of Manufacturing Associates
- Oversees and coordinates the execution of the manufacturing schedule through daily shift assignments and huddles
- Maintains a safe and current good manufacturing practice (cGMP) compliant environment by ensuring direct reports have correct and up-to-date training
- Supports manufacturing investigations and continuous improvement projects
- Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment
- Supports Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Operational Qualification (OQ), and Performance Qualification (PQ)
- Manages and develops direct reports from Filling team
Other
- High School diploma/GED with 9 years of related experience in large pharma/biotech operations or projects
- Bachelor’s degree in Life Science, Engineering, or related field with 5 years of related experience in large pharma/biotech operations or projects
- Proven ability to lead teams
- 1-3 years of leadership experience
- Ability to stand for prolonged periods of time - up to 240 Minutes
