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Summary: The Validation Project Manager will be responsible for managing the execution of multiple validation related projects at FDB Texas facilities.
- Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals.
- Coordinate resources and personnel to achieve company and department goals
- Pre-approve and post-approve qualification protocols.
- Execute validation protocols (when required).
- Prepares validation master plans for facilities, equipment, and systems.
- Approves the resolution of discrepancies encountered during protocol execution.
- Approves qualification summary reports.
- Investigate and close-out exception reports and non-conformances associated with validation studies.
- Assist in continuous improvement for the department by evaluating systems to improve functionality and efficiency.
- Performs other duties as needed.
Required Skills & Abilities:
- Demonstrated knowledge and experience in utilities, facilities and process equipment systems for biopharmaceutical products.
- Demonstrated knowledge and experience with the facility validation during start-up.
- Demonstrated knowledge and experience in clean room qualifications.
- Demonstrated knowledge of cGMP compliance.
- Excellent written and oral communication skills.
- Working knowledge of Microsoft Office products (Project, 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: thermal mapping equipment, fog machine, air sampling equipment.
- Working on ladders.
- Attendance is mandatory.
Validation Project Manager Minimum Qualifications:
- Bachelor's Degree preferably in Engineering or Life Sciences or and 6 years of experience in validation activities including 2 years managing the execution of validation projects.
- 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.