Senior Data Science Engineer

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The Manufacturing Sciences (MS) Senior Data Science Engineer I is responsible for managing Continuous Process Verification (CPV) activities including routine evaluation, escalation of signals, cross-functional meetings, statistical analyses, and Product Quality Reviews (APQR, YBPR). The role contributes to the technical management of GxP and non-GxP systems (e.g., Statistica, Spotfire, SIMCA) and ensures data integrity and usability through data stewardship and engineering solutions.

Key areas of accountability include modifying and maintaining Statistica work spaces (Statistica Administrator duties), managing control limits, and supporting Takeda’s digital Capabilities. Subject matter expertise is required in distributed control systems, PI historian, Statistica, Discoverant, LIMS, JMP and other multivariate process analytical tools. The role involves identifying potential improvement projects using advanced analytics and process knowledge. Experience in a commercial manufacturing facility and GxP environments is preferred.

Prior project management experience implementing similar systems/programs at biotech or biopharma companies is also required. Strong cross-functional collaboration skills are essential. Be a data steward, ensuring data integrity, visibility, and usability. Support data engineering solutions to automate GxP activities. May support Manufacturing investigations as a digital and statistical expert.

• Lead CPV program initiatives including APQR, PQR, YBPR, and cross-functional meetings.
• Perform statistical analyses.
• Evaluate control limits and monitoring strategy.
• Act as a subject matter expert (SME) for Statistical Process Control (SPC).
• Ensure data integrity, visibility, and usability through stewardship initiatives.
• Execute data science and data engineering solutions to automate GxP and non-GxP activities to enhance operational efficiency.
• Drive and support transformative digital projects to advance Takeda’s digital culture and ways of working.
• Statistica Administrator: manage end users, develop automations, develop and maintain work spaces.
• Support MA Bio Ops end users for applicable dashboards and regulatory/RTQ data requests.
• Statistical analysis support.
• Support regulatory inspections including routine GMP inspections.
• Expertise in multivariate modeling methods (e.g., PCA/PLS, OPLS, discriminant analysis).
• Collaborate with SMEs to collect and process data for modeling using automated tools (e.g., VBA, R, Python).
• Assess and design phased project plans based on readiness of peripheral systems and resource availability.

• Bachelor’s degree in an engineering discipline, biological sciences, or business with a strong background in life sciences operations; minimum 5 years of combined experience or Master’s degree with 3 years in a GMP production environment (SAP/ERP or MES).
• Understanding of manufacturing operations and related functions from supply chain planning to product release.
• Proficiency in managing systems and platforms (e.g., Statistica or other data science tools).
• Knowledge of SPC and statistical methods.
• Proven ability to write maintainable code in Python or R.
• GxP software validation; data governance and stewardship.
• Data mining, machine learning, and statistical modeling experience.
• Experience with Large Language Models (LLMs) in pharmaceutical applications is a plus.
• Knowledge of tools such as TIBCO Data Science, Statistica, Spotfire, SIMCA, Discoverant, Databricks, Qlik, Tableau, Power
  
  BI, Power Automate, AWS, and big data platforms.
• Strong collaboration and communication skills; ability to work with multifunctional teams at all levels.
• Familiarity with systems validation execution and related documentation.
• Knowledge of statistics for process monitoring and GMP manufacturing…