Sr. Validation Engineer
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: May 12, 2022
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
- 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
- Prepares validation master plans for facilities, equipment, and
- Prepares and executes validation protocols.
- Prepares validation report packages.
- Provides expert opinion in the drafting and implementation of
- Coordinates the timely execution of validation activities.
- Performs others duties as may be assigned.REQUIRED SKILLS &
- Experience with Thermal Data Loggers as well as pre and post
- 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
- Working knowledge and expertise in steam sterilization
- Working knowledge and expertise in computerized systems
validation.WORKING CONDITIONS & PHYSICAL REQUIREMENTSThe 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
- Experience prolonged sitting, some bending, stooping and
- 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
- cGMP experienceWe 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 or call .
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Sr. Validation Engineer, Engineering , College Station, Texas
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