Staftonic LLC · 15 hours ago
Senior Validation Engineer
Washington, United States
Contract
Onsite
Senior Level, Lead/Staff
8+ years expStaftonic LLC is seeking a Senior Validation Engineer to lead Environmental Monitoring Performance Qualification (EMPQ) activities for a biologics manufacturing site. The role involves planning, executing, and closing out EMPQ activities in a GMP-regulated cleanroom environment.
Information Technology & Services
No H1B
Hiring Manager
Shaik Aleem
Responsibilities
Lead EMPQ planning, execution, and close-out for GMP cleanrooms
Author and review EMPQ Validation Plans, protocols, and final reports
Oversee execution of viable and non-viable environmental monitoring
Review and interpret EM data, including trending and alert/action limits
Ensure EMPQ activities are inspection-ready (FDA / regulatory)
Work closely with Quality, Validation, Facilities, and Operations
Provide technical guidance to junior validation staff when needed
Qualification
Required
8+ years of GMP validation experience in biotech or pharmaceutical manufacturing
Proven experience owning EMPQ (not just supporting it)
Strong understanding of cleanroom control strategies
Hands-on experience with Environmental monitoring systems
Hands-on experience with Particle counters
Hands-on experience with Active air samplers
Hands-on experience with Microbiology support equipment (incubators, BSCs, laminar flow hoods)
Strong technical writing and documentation skills
Experience supporting regulatory inspections
Company
Staftonic LLC
At Staftonic, we believe in turning possibilities into realities.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase