Validation Engineer
Core
Lead validation lifecycle activities for equipment, utilities, facilities, and computerized systems in highly regulated pharmaceutical, biotechnology, and medical device environments.
Role type
Senior Validation Engineer
Builds
Validated equipment, utilities, facilities, and computerized systems for life-enhancing therapies
Domain
Pharmaceutical / Biotechnology / Medical Device
Required skills
cGMP compliance, FMEA, risk-based validation, equipment validation, computerized systems validation (CSV), analytical methods, process validation, IQ/OQ/PQ documentation, regulatory inspection support, root-cause analysis, P&ID walkdowns, thermal mapping
Preferred skills
Mentoring junior engineers, cross-functional collaboration, change control management
Technologies
GMP, FMEA, CSV, IQ/OQ/PQ, P&ID, thermal mapping tools
Responsibilities
Lead preparation and execution of validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) for GMP-regulated assets; Oversee validation activities for internal and client technology-transfer projects including risk assessments and validation plans; Write, review, and update qualification documentation including SOPs, validation master plans, and user requirements specifications; Prepare comprehensive summary reports for validation, verification, and commissioning activities; Lead P&ID walkdowns to verify system installation and configuration; Perform and oversee thermal mapping activities for temperature-controlled systems; Support investigation and resolution of regulatory observations and audit findings; Provide technical guidance and mentorship to junior validation engineers.
Seniority
Senior, hands-on IC with mentorship responsibilities