QA/Remediation Validation Engineer

Location

College Station, TX | United States

Job description

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 QA/Remediation Validation Engineer 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 

Primary Responsibilities:

• Validation liaison for Customer and Regulatory Audits 
• Generates validation related audit responses.
• Manages validation audit commitments to meet deadlines.
• Supports validation remediation projects 
• Pre-approve and post-approve qualification protocols.
• Execute validation protocols (when required).
• Supports procedures / policy revisions from audit commitments.
• Assist in continuous improvement for the department by evaluating systems to improve functionality and efficiency.
• Performs other duties as assigned or special projects as needed.

Qualifications:

• 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.

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.

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 [email protected] 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.

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