Sr. Validation Engineer

SUMMARY  The Senior Validation Engineer, under minimal supervision, will be responsible for drafting and executing utility, process systems and process support systems qualification test work across multiple GMP facilities as well as support cleaning and process validation when necessary. Preparing validation summary reports for the qualification and validation of systems used to manufacture drug or biologics products.

External US

ESSENTIAL FUNCTIONS

• Develop, implement and maintain equipment and systems qualification and validation protocols. Systems include:
  • Steam and Dry Heat Sterilizers
  • Refrigerators, Freezers, and Cold Rooms
  • Clean Gas Utilities
  • Purified Water and Water For Injection
  • Process Chromatography Systems
• Execute, track and manage protocols
• Prepare and present report packages for implementation into SOP requirements
• Prepares validation master plans for facilities, equipment, and systems.
• Prepares and executes validation protocols.
• Prepares validation report packages.
• Provides expert opinion in the drafting and implementation of validation studies.
• Coordinates the timely execution of validation activities.
• Performs others duties as may be assigned.

REQUIRED SKILLS & ABILITIES

• Experience with Thermal Data Loggers 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).
• Ability to work with minimal supervision.
• Working knowledge and expertise in clean room qualification.
• Working knowledge and expertise in steam sterilization processes.
• Working knowledge and expertise in computerized systems validation.

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: temperature logger equipment, fog machine, air sampling equipment
• Working on ladders.
• Attendance is mandatory.

MINIMUM QUALIFICATIONS

• Bachelor of Science preferably in Life Sciences, Chemical or Mechanical Engineering; and 5 - 7 years of experience in validation activities in facilities, commissioning, and systems qualification of which at least 1 year must be in a lead role.

PREFERRED QUALIFICATIONS    

• cGMP experience

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 email FDBTHR@fujifilm.com or call 979-431-3528.