Drive the execution and adoption of the process data analytics (PA) technologies and capabilities for the Biologics (BIO) business unit (BU).
Build and maintain Discoverant product hierarchies for global BIO programs according to standard best practices for manufacturing process modelling and nomenclature under a formal SDLC change control process.
Partner with global and site MSAT to build and deliver user requirements and streamline the execution of Continued Process Verification (CPV), routine process monitoring, and external data sharing activities through usage of Discoverant.
Develop and integrate data visualization solutions into existing MSAT workflows including manufacturing process and material genealogy use cases.
Work collaboratively to engage site leadership and technical SMEs to advance programs related to global process analytics.
Liaise with Global IT, Computerized Systems Validation (CSV), and Data Engineering and Process Analytics (DEPA) to adhere to Discoverant platform-level best practices and procedures and provide input for future system enhancements and upgrades.
Investigate the applicability of advanced analytical tools such as real-time multivariate process modelling or process knowledge management for improving development and manufacturing.
Support or lead projects related to Pharma 4.0, AI/ML, and other digital transformation initiatives for the BIO BU.

Requirements

Bachelor’s Degree in Computer Science, Chemical Engineering, or STEM related discipline
3 + years of Computerized Systems Engineering, Data Engineering, or Data Analytics experience in a biopharmaceutical GMP manufacturing environment.
Experience building and configuring process analytics data management systems such as Skyland PIMS, BIOVIA Discoverant, or TIBCO Statistica.
Experience with systems integration, building SQL queries against relational databases for applications commonly used in pharmaceutical manufacturing facilities such as laboratory information management systems (LIMS), enterprise resource planning (ERP) systems, manufacturing execution systems (MES), distributed control systems (DCS), process data historian systems (AVEVA PI).
Experience working with statistical analytics platforms (JMP/Minitab/R), data visualization applications (Power BI, Tableau, Spotfire) or programming languages (Python, Visual Basic, HTML/CSS) is a plus.
Strong working knowledge of Statistical Process Control (SPC), Continued Process Verification (CPV), and basic statistics tools and methodologies is a plus.
Working knowledge of the overall Biologics development and manufacturing process.
Experience working in a cGMP Software Development Lifecycle (SDLC) environment.
Ability to work in a matrix management system and influence and negotiate collaboratively with others without direct authority.
Strong project management skills with proven ability to independently manage multiple milestones flexibly in an environment where priorities may change at short notice.
Experienced with writing quality-controlled computerized systems design documents, policy documents and SOPs.
Experienced in participating and leading process improvement and PPI Kaizen projects including the application of Lean/Six Sigma methodologies.
Ability to work independently with minimal daily supervision.
Ability to work outside normal business hours on a semi-regular basis to connect with colleagues in U.S., Europe, and Asia-Pacific time zones.

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data analyticsprocess analyticsdata visualizationSQLstatistical analyticsStatistical Process ControlLeanSix Sigmaprogramming languagesGMP manufacturing

Soft Skills

project managementcollaborationinfluencenegotiationindependenceflexibilitycommunicationleadershipproblem-solvingadaptability