Senior Data Science Engineer I

Takeda•Lexington, MA

1d•$89,900 - $141,240•Onsite

About The Position

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 workspaces (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.

Requirements

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, PowerBI, 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 the use of Microsoft Office
Knowledge of GMP manufacturing processes
Aptitude/interest in developing new insights for manufacturing operation management, and willingness to learn new technologies, standards and best practices.
Good understanding of biopharmaceutical batch manufacturing, material flow, unit operations and scheduling/planning
Ability to apply industry regulations and best practices to decision making process
Commitment to sound methodologies and best practices
Participate in problem resolution meetings/teams effectively
Ability to shift priorities to meet required deadlines
Effectively communicate issues cross-functionally and resolve them in a timely manner
Trained on relevant industry regulations and cGMP compliance
Excellent presentation skills
Strong problem-solving skills and attention to detail.

Nice To Haves

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.

Responsibilities

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 workspaces.
Support MA BioOps 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 BioOps 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.