Senior Data Science Engineer

About the Role

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 (i.e. Statistica Administrator duties), managing control limits, and supporting Takeda’s digital Capabilities. Have specific subject matter expertise in process of distributed control systems, PI historian, Statistica, Discoverant, LIMS, JMP and other multivariate process analytical tools. Expertise to identify potential improvement projects utilizing advanced analytics and process knowledge. Working in commercial manufacturing facility and GxP experience is preferred.

Previous project management implementing similar systems/programs at other biotech or biopharma companies is also required. Strong cross 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, cross functional meetings.
• Perform statistical analyses.
• Control limits and monitoring strategy evaluation.
• 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 digital ways of working.
• Statistica Administrator:
  Manage end users, develop automations, develop and maintain work spaces.
• Support MA Bio Ops end users for applicable dashboards Regulatory and RTQ data requests.
• Statistical analysis support.
• Support regulatory inspections including routine GMP inspection.
• Have expertise in multivariate modeling methods, including PCA/PLS, OPLS, Discriminant analysis, etc. Support MA Bio Ops end users for applicable dashboards.
• Work with SMEs to collect and process data for use in creating models, utilizing a variety of automated tools (e.g. VBA, R/Python).
• Individual will be able to assess and design a phased approach in the project plan based on readiness of peripheral systems, design and building of process models and capital/resource availability.

• Bachelor’s degree in an engineering discipline, biological sciences or business (with a strong background in life sciences operations) with a minimum of 5 years of combined experience or Master’s degree with 3 years of experience in production environment utilizing GMP systems for supply chain (SAP or any other ERP) or manufacturing operations management such as MES (Manufacturing Execution Systems).
• Sound 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 including statistical methods.
• Proven ability to write maintainable code in programming languages (Python or R).
• GxP software validation;
  Data governance and stewardship.
• Data mining, machine learning, statistical modeling.
• Some experience with Large Language Models (LLM) in Pharmaceutical applications.
• TIBCO Data Science / Statistica, TIBCO Spotfire, SIMCA, Discoverant, Databricks Qlik, Tableau, Power
  
  BI, Power Automate, AWS, Big Data platforms.
• Ability to interact well in multifunctional teams and with personnel at all levels in the organization.
• Familiar with systems validation execution and related documentation.
• Knowledge of statistics for process monitoring.
• Strong written and verbal communication skills.
• Proficient in…