Home Careers Validation Specialist III

Validation Specialist III

College Station, Texas

ESSENTIAL FUNCTIONS

  • Generate and obtain approval for lifecycle documents such as System Impact Assessments, User Requirements Specifications and Risk Assessments according to validation SOPs.
  • Generate and obtain approval for qualification and validation protocols for systems including:
    • Clean Utilities
    • Cleanrooms
    • Steam Autoclaves
    • Refrigerators, Freezers, and Cold Rooms
    • Bioreactors
    • Chromatography Skids
    • Isolators
    • Biological Safety Cabinets
  • Execute, track and manage protocols
  • Generate and obtain approval for summary reports
  • Perform other duties as assigned

REQUIRED SKILLS & ABILITIES

  • Experience with Thermal Data Loggers such as the Kaye Validator as well as pre and post calibration procedures.
  • Working knowledge of cGMP compliance.
  • Excellent written and oral communication skills.
  • Knowledge of utility and process systems associated with the manufacture of a biopharmaceutical product.
  • Strong working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, PowerPoint)

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged sitting, some bending, stooping and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Operation of test equipment such as: Kaye validator, fog machine, air sampling equipment
  • Working on ladders.
  • Attendance is mandatory.

MINIMUM QUALIFICATIONS

  • Minimum 3 years of experience performing validation activities

PREFERRED QUALIFICATIONS    

  • cGMP experience

Essential Functions:

  • Prepares and executes validation protocols.
  • Prepares validation final report packages.
  • Performs other duties as assigned.

Required Skills & Abilities:

  • Working knowledge of cGMPs
  • Experience writing and executing validation protocols
  • Experience writing validation final reports
  • Excellent written and oral communication skills
  • Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint).

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged sitting, some bending, stooping and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Operation of test equipment such as: Kaye validator, fog machine, air sampling equipment
  • Working on ladders

Qualifications:

  • 2-4 years of validation experience in a regulated environment

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.

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