Continuous Improvement Lead – Commissioning & Qualification (C&Q)
Core
Lead continuous improvement initiatives to strengthen digital enablement, process standardization, and operational excellence for Engineering commissioning and qualification programs.
Role type
Continuous Improvement Lead (Commissioning & Qualification)
Builds
Standardized C&Q processes, digital tools, and best practices for Engineering projects and manufacturing facilities.
Domain
Pharmaceutical/Biotechnology Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based qualification methodologies, GMP documentation practices, Data integrity principles, Cross-functional collaboration, Process standardization, Digital transformation implementation, Kneat platform experience, Metrics and reporting development, Lifecycle validation approaches, Global process standardization
Preferred skills
Digital validation lifecycle management tools, Large-scale capital project support, Data analytics and reporting automation, Operational excellence frameworks, Inspection readiness initiatives
Technologies
Kneat, Power BI, Tableau, Smartsheet
Responsibilities
Lead continuous improvement initiatives for C&Q document preparation and digital execution, Establish governance for C&Q digital tools and documentation standards, Drive optimization and adoption of digital validation tools, Develop standardized templates and workflows for C&Q, Partner with Engineering, Validation, Quality, and Manufacturing teams, Monitor performance metrics for efficiency and compliance, Provide training and support for digital tools, Ensure alignment with GMP and regulatory expectations
Seniority
Senior, hands-on IC
