Process Sciences-Continued Process Verification (CPV) Associate Data Analyst

Overview

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.

Summary: The Continued Process Verification (CPV) Data Analyst functions within a team-based organization. The individual is responsible for gathering, analyzing, visualizing, and reporting data for GMP commercial manufacture performance evaluation of biological drug processes. This individual must work in a collaborative manner coordinating data acquisition and interpretation of visualized analysis results from internal and client groups within a CDMO environment.

External US

Essential Functions:

• Applies scientific, statistical, and cGMP manufacturing expertise to analyze data for process performance evaluation.
• Provide data summary for routine process monitoring.
• Utilizes standard software programs from data storage, statistical analysis, and visualization.
• Applies data integrity principles for data acquisition, transformation, analysis, and reporting
• Develop methods to enhance efficiencies associated with gathering, analyzing, visualizing, and reporting of data.

• Author CPV plans, CPV reports, and campaign summary reports using Good Documentation Principles (GDP).
• Execute various statistical methods to aid in process troubleshooting.
• Visualization of project and organizational metrics
• Perform all other duties as assigned.

Required Knowledge/Technical Expertise

Individual will have knowledge/expertise relevant to:

• Working within cGMP environments in relation to biologics and vaccine manufacturing.
• Proficient with statistical methods and concepts.
• Document writing including plans and summary reports.

• Experience with JMP (or comparable Statistical Analysis software), Microsoft Excel, Word, and PowerPoint.
• Familiarity with development and execution of imbedded scripts
• Ability to apply skills and knowledge to communicate effectively with Process Automation, Global Information Technology, and Global Data Science support groups

Other Abilities:

• Build credibility by performing high quality work.
• Expand the technical capabilities of Process Sciences team through mentoring and hands-on support.
• Supports other members of the team with respect to the day-to-day goals and activities by imparting their expertise to the group.
• Effectively communicates results of own work through meetings, presentations, discussions, and documentation with some input from supervisor.
• Minimum supervision required on day-to-day activities and accomplished tasks.

• The ability to work in a team-oriented environment is essential, as this person will work closely with other team members and clients.

• Self-motivated and capable of demonstrating technical competence.  
• Excellent interpersonal communication skills and ability to influence and collaborate in a team environment.
• Analytical and excellent problem-solving skills.

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 standing, along with some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.

• Ability to wear personal protective equipment to include safety glasses, lab coat, gloves or other equipment as required.
  • Attendance is mandatory.

Minimum Qualifications:

• Master’s Degree; OR
• Bachelor’s Degree at least 2 years of relevant experience; OR
• Associate’s Degree with 4 years of relevant experience.

Preferred Qualifications:

• Degree preferably in Engineering, Chemistry, Biology, Life Sciences or related field.
• Work experience in a cGMP environment.

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.