Validation Project Manager
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 13, 2022
Overview At FDB, your passion - your Genki - is your power.
Here, your passions will be recognized, nurtured, fueled, and
celebrated by those around you.Join FDB and join other motivated
individuals who fuel one another's passions and embrace every day
as an opportunity for impact where we know it matters most: human
lives.Advance tomorrow's medicines with us!Summary: - The
Validation Project Manager will be responsible for managing the
execution of multiple validation related projects at FDB Texas
facilities. External US Essential Functions:
- Effectively schedule validation activities in co-operation with
other departments, company priorities, and department goals.
- Coordinate resources and personnel to achieve company and
- Pre-approve and post-approve qualification protocols.
- Execute validation protocols (when required).
- Prepares validation master plans for facilities, equipment, and
- Approves the resolution of discrepancies encountered during
- 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
- 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
- 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
- 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 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 FDBTHR@fujifilm.com
or call 979-431-3528. -
Keywords: FDBT - FUJIFILM Diosynth, College Station , Validation Project Manager, Executive , College Station, Texas
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