Project Manager, Validation
- FUJIFILM Diosynth Biotechnologies
- College Station, TX
- Start date
- Mar 21, 2023
- Engineering, Manufacturing & Production, Facilities & Site
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Lone Star Bio
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Project Manager, Validation will be responsible for managing the execution of multiple validation related projects at FDBT facilities.
Reports to Associate Director, Validation
Work Location College Station, TX
- 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.
- Bachelor's Degree, preferably in Engineering or Life Sciences, and 6+ years of experience in validation activities in a pharmaceutical or biotechnology environment.
- 2+ years managing the execution of validation projects.
- 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).
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
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.
Join us! FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.
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 979-431-3500.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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.
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
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