Sr Associate Technical Engineer
Core
Sr Associate Technical Engineer responsible for implementing and sustaining Continuous Improvement projects and Validation Master Plan elements for clean utilities and equipment cleaning at a pharmaceutical manufacturing site.
Role type
Senior IC Technical Engineer (Validation & Clean Utilities)
Builds
Validated clean utility systems, equipment cleaning protocols, and compliant manufacturing processes
Domain
Pharmaceutical manufacturing / Clean utilities / Equipment validation
Required skills
cGMP and FDA regulations knowledge, cleaning validation expertise, equipment qualification, risk assessment, SOP development, project milestone management, vendor management, data analysis, trend monitoring, mechanical ability, heavy gowning compliance
Preferred skills
Experience with generative AI tools (ChatGPT, Copilot), change management, cross-functional collaboration
Technologies
ChatGPT, Microsoft Copilot
Responsibilities
Develop and execute cleaning validation and equipment qualification protocols; Author and approve technical reports, SOPs, and validation plans; Manage project milestones for new processes and equipment installations; Coordinate with Operations, Engineering, and Quality functions; Support regulatory and internal audits; Maintain shop floor presence in clean room environments.
Seniority
Senior, hands-on IC