Associate Validation & Qualification
Core
Support Technology Transfer activities, execution of validation batches, and ensure compliance with regulatory requirements for safe and effective products.
Role type
Associate Validation & Qualification Engineer
Builds
Validation batches, technical documentation, and regulatory submissions
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
validation principles, cGMP compliance, regulatory guidelines (FDA), statistical analysis, technical writing, equipment qualification, protocol development, deviation investigation, data evaluation
Preferred skills
laboratory process validation, AI tools (ChatGPT, Copilot), cross-functional collaboration, continuous learning
Technologies
Microsoft Office (Excel)
Responsibilities
Execute laboratory and scale-up validation batches; prepare and review study protocols and technical reports; evaluate and approve validation master plans and reports; troubleshoot validation problems and conduct statistical analysis; write and approve validation process documents; manage regulatory queries and responses; participate in deviation investigations; support cGMP training initiatives.
Seniority
Associate, entry-level with supervision
