Validation Engineer
Core
Define and implement validation strategies for pharmaceutical manufacturing processes to ensure quality and regulatory compliance.
Role type
Validation Engineer (Pharmaceutical Manufacturing)
Builds
Pharmaceutical manufacturing processes and equipment
Domain
Biopharmaceuticals / Sterile injectables / Equipment preparation and filling
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation and qualification expertise, Knowledge of cGMP/BPF/ICH/Pharmacopoeia, Process and equipment validation practices, Project management, Cross-functional resource management, Regulatory impact assessment
Preferred skills
Experience in sterile/injectable processes or equipment preparation/filling/visual inspection/packaging, AI tools proficiency
Technologies
cGMP, BPF, ICH, Pharmacopoeia, AI tools
Responsibilities
Ensure project delivery within timelines and protocols, Draft validation plans and approve protocols/reports, Participate in internal site meetings for major projects, Manage allocated validation resources, Present validations during inspections and audits, Monitor GMP/STD regulatory updates and evaluate impacts on validation practices
Seniority
Mid-Senior, hands-on IC
