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Validation Project Manager

Employer
FUJIFILM Diosynth Biotechnologies
Location
College Station, TX
Start date
Aug 3, 2022
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Job Details

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 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.

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

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Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
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