Manufacturing Support Specialist 3

7 hours ago


Mount Holly Springs, Pennsylvania, United States FUJIFILM Holdings America Corporation Full time
About This Role

The primary function for the Manufacturing Specialist 3, Drug Product is to provide ownership to support operational readiness and sustaining operations to the Drug Product Manufacturing Inspection area.

Key Responsibilities
  • Provides expertise in manual and automated visual inspection for the installation and qualification and validation of equipment as well as definition and initiation of operational processes
  • Supports and provides expertise in manual and automated visual inspection
  • Creates and manages process flow diagrams and initiate process improvements for Drug product manufacturing
  • Analyzes potential product line for facility fit
  • Provides support to associated Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and any other testing, as required
  • Supports manufacturing technology team in tech transfer
  • Provides support and expertise in audits and in client facing troubleshooting
  • Owns the development and maintenance of defect sets
  • Drives continuous improvement and optimization efforts for Drug product inspection area
  • Creates and reviews user requirement specifications and manages through their lifecycle
  • Owns operational process development and associated documentation including risk assessments and critical process parameters and critical quality attributes
  • Provides expertise to support client and regulatory audits of the drug product inspection area
  • Designs and delivers technical training on processes to new employees of all levels
  • Collaborates with global DPM team and on site cross functional DPFG team
  • Owns and drives product specific automated inspection recipe development
Requirements
  • High School Diploma or GED and 14 years of direct experience
  • OR Associates Degree and 12 years of direct experience
  • OR Bachelor's Degree and 8 years of direct experience
  • OR Equivalent Military training or experience
Preferred Requirements
  • Associates Degree in Life Sciences or Engineering
  • BA/BS in Life Sciences or Engineering
  • Expertise in manufacturing operations, including sequence and cadence of activities
  • Previous experience with ERP system (SAP)
  • Experience with Visual Inspection processes and USP790
  • Highly proficient in manufacturing systems (for example, SAP)
  • SME in the creation and revision of manufacturing documentation
  • High degree of experience leading improvement projects, investigations, change controls and CAPAs
  • Experienced in audits and inspection
Working Conditions & Physical Requirements

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Ability to stand for prolonged periods of time.

Ability to sit for prolonged periods of time

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to operate machinery and/or power tools.

Ability to conduct work that includes moving objects up to 33 pounds.

FDBN is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.



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