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

Fujifilm - College Station, TX

Full-time - Entry Level

College Station, TX

Machinery Manufacturing

About the position

The Continued Process Verification (CPV) Associate Data Analyst plays a crucial role in the evaluation of biological drug processes within a team-oriented environment. This position involves gathering, analyzing, visualizing, and reporting data to assess GMP commercial manufacturing performance. The analyst collaborates with internal and client groups to ensure effective data acquisition and interpretation, contributing to the overall success of the organization in the biopharmaceutical industry.

Responsibilities

• Gather, analyze, visualize, and report data for GMP commercial manufacture performance evaluation of biological drug processes.
• Apply scientific, statistical, and cGMP manufacturing expertise to analyze data for process performance evaluation.
• Provide data summary for routine process monitoring.
• Utilize standard software programs for data storage, statistical analysis, and visualization.
• Apply data integrity principles for data acquisition, transformation, analysis, and reporting.
• Develop methods to enhance efficiencies in data handling processes.
• Author CPV plans, CPV reports, and campaign summary reports using Good Documentation Principles (GDP).
• Execute various statistical methods to aid in process troubleshooting.
• Visualize project and organizational metrics.
• Perform all other duties as assigned.

Requirements

• Master's Degree; OR Bachelor's Degree with at least 2 years of relevant experience; OR Associate's Degree with 4 years of relevant experience.
• Knowledge of working within cGMP environments related to biologics and vaccine manufacturing.
• Proficiency with statistical methods and concepts.
• Experience with JMP or comparable statistical analysis software, Microsoft Excel, Word, and PowerPoint.
• Familiarity with development and execution of embedded scripts.
• Ability to communicate effectively with Process Automation, Global Information Technology, and Global Data Science support groups.

Nice-to-haves

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

Benefits

• Competitive salary
• Health insurance
• Retirement savings plan
• Paid time off
• Professional development opportunities