Manager, Process Performance Qualification
Core
Leads a team of validation engineers for Process Qualification, Cleaning Validation, and Continued Process Verification (CPV) supporting sterile injectable manufacturing operations.
Role type
Manager, Process Performance Qualification
Builds
Validated manufacturing processes and cleaning programs for sterile injectables
Domain
Pharmaceutical manufacturing / Biopharmaceutical / Sterile manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership, Validation lifecycle management, Process improvement, Risk-based solutions, Regulatory compliance, Cross-functional collaboration, Technical troubleshooting, Change management, Statistical analysis, Talent development
Preferred skills
Leading regulatory inspections, Process innovation, Generative AI tool usage, Pharmaceutical validation expertise, Complex project management
Technologies
Microsoft Copilot, Generative AI tools
Responsibilities
Lead and mentor validation engineers; Establish Validation Master Plans; Drive process improvements and risk-based solutions; Solve technical validation challenges; Support investigations and change controls; Represent validation programs in regulatory inspections and audits; Develop talent and coaching programs; Monitor validation performance metrics.
Seniority
Manager, people leadership & technical oversight