Product and Technology Lead
Core
Lead Product Lifecycle Management (PLM), Process Validation, Cleaning Validation, Continued Process Verification (CPV), Package Validation, and Technical Governance for pharmaceutical products manufactured at the site.
Role type
Senior IC Product and Technology Lead (Pharmaceutical Manufacturing)
Builds
Validated pharmaceutical products and compliant manufacturing processes
Domain
Pharmaceutical manufacturing / Consumer healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing validation & process control)
Required skills
Process validation, Cleaning validation, Continued Process Verification (CPV), Technical risk assessment, Root cause analysis, Statistical process monitoring, Regulatory compliance (GMP), Product lifecycle management
Preferred skills
Cross-functional stakeholder management, Inspection readiness, Strategic technical initiative leadership
Technologies
Process monitoring tools, Data trending tools, Validation software
Responsibilities
Manage Product Lifecycle Management (PLM) activities and oversight of all Validation Lifecycle activities; Develop and maintain site validation strategies; Serve as technical owner for product formulations, manufacturing processes, and Critical Quality Attributes; Lead technical assessments for product changes and investigations; Oversee technical investigations, deviations, and CAPA activities; Implement and maintain CPV programs; Collaborate cross-functionally with Engineering, Quality, Operations, and Global Technical teams.
Seniority
Senior, hands-on IC
