Senior Validation Engineer
Core
Lead complex validation projects and ensure compliance with cGMPs and GxP guidelines for sterile products and medical devices.
Role type
Senior Validation Engineer (Pharmaceutical/Medical Devices)
Builds
Qualified systems, processes, utilities, facilities, and computer systems for sterile products and medical devices
Domain
Pharmaceutical manufacturing and medical device production
Required skills
cGMPs, ISPE, Data Integrity, 21 CFR Part 11, IQ/OQ/PQ, SOPs, validation planning, protocol authoring, root cause analysis, regulatory audit support, change control, deviation management
Preferred skills
Equipment qualifications, CSV, Aseptic validations, process/cleaning validations, sterile product validation, medical device validation, multi-workstream exposure
Technologies
Computerized systems, sterility assurance equipment, capex qualifications
Responsibilities
Lead complex validation projects and develop work plans, provide data analysis for quality investigations, author/approve protocols and reports, execute on-floor validations, coordinate testing with functional groups, maintain Site Validation Master Plan, support regulatory audits, troubleshoot validation issues, assess impact of system changes, implement validation best practices, support product transfers and new product development, integrate validation schedules with production schedules, participate in deviation investigations
Seniority
Senior, hands-on IC