Validation Engineer
Core
Own the validation program for a regulated infant formula manufacturing facility, ensuring compliance with FDA regulations and proving product safety through rigorous testing and documentation.
Role type
Senior Validation Engineer (Regulated Manufacturing)
Builds
Validated equipment, processes, cleaning procedures, and computer systems for organic infant formula production.
Domain
Food & Beverage / Infant Formula Manufacturing / Regulatory Compliance
Required skills
Validation protocol design and execution (IQ/OQ/PQ), Process validation, Cleaning validation (CIP), Computer system validation (CSV), Risk assessment, Change control management, Statistical process control (SPC), Technical writing for regulatory audits
Preferred skills
21 CFR 106/107/113/117 knowledge, HACCP study design, Environmental monitoring program design, eQMS/LIMS proficiency, ASQ CQE/CQA or SQF Practitioner certification
Technologies
TrackWise, Optiva, GLIMS, eQMS, LIMS
Responsibilities
Develop and maintain the Validation Master Plan; Author and execute validation protocols for new/modified equipment and processes; Manage annual CCP/OPRP verification and cleaning verification; Oversee computer system validation and 21 CFR Part 11 controls; Integrate validation into capital projects from URS through PQ; Support CAPA teams and deviation investigations with validation data; Maintain audit-ready records for FDA, SQF, and USDA Organic inspections.
Seniority
Mid-Senior level, hands-on individual contributor owning a site-wide program.
