Validation Engineer
Core
Develop documentation, write and execute protocols, and generate summary reports for Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Role type
Senior CQV Engineer (Commissioning, Qualification, and Validation)
Builds
Validation documentation and execution plans for pharmaceutical manufacturing facilities and utilities
Domain
Life Sciences / Pharmaceutical Manufacturing / GMP-regulated environments
Required skills
Protocol writing and execution, Field verification, Summary report development, FAT/SAT execution, System walkdowns, IQ/OQ/PQ generation, URS review, P&ID interpretation, GMP compliance, Troubleshooting, Project lifecycle management
Preferred skills
Baseline Guide 5 knowledge, Isolator qualification, VHP cycle development, Biotech/aseptic processing experience, Gene Therapy experience
Technologies
Microsoft Word, Microsoft Excel
Responsibilities
Support documentation for C&Q of facilities, utilities, and equipment; Manage C&Q documentation lifecycle from SLIA to OQ; Provide cGMP leadership for client delivery; Execute field verification and troubleshooting; Support onsite/offsite activities including FATs, SATs, and system walkdowns.
Seniority
Mid-to-Senior, hands-on IC