Staftonic LLC · 8 hours ago
Senior Validation Engineer (EMPQ)
Washington, United States
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expStaftonic LLC is seeking a Senior Validation Engineer to lead EMPQ planning, execution, and close-out for GMP manufacturing and cleanroom spaces. The role involves authoring and approving validation plans, developing risk assessments, providing technical oversight, and collaborating with various teams to ensure inspection readiness.
Information Technology & Services
Hiring Manager
Shaik Aleem
Responsibilities
Lead EMPQ planning, execution, and close-out for GMP manufacturing and cleanroom spaces
Author, review, and approve EMPQ Validation Plans, Qualification Protocols, and Summary Reports
Develop and update environmental monitoring risk assessments and contamination control strategies
Provide technical oversight for:
Active air samplers
Portable and fixed particle counters
Viable and non-viable EM systems
Oversee validation readiness of microbiology support equipment:
Incubators (20–25°C, 30–35°C, CO₂)
Biosafety cabinets & laminar flow hoods
Colony counters
Review, analyze, and interpret EMPQ data, including trending, alerts, and action limits
Collaborate closely with QA, Facilities, and Operations to ensure inspection readiness
Mentor and guide junior validation staff supporting EMPQ activities
Qualification
Required
8+ years of GMP validation experience in biotech or pharmaceutical manufacturing
Proven end-to-end EMPQ ownership (planning → execution → reporting)
Strong understanding of cleanroom control strategies and environmental monitoring programs
Hands-on experience with microbiology and EM-related QC equipment
Excellent technical writing and inspection-ready mindset
Ability to work independently and lead cross-functional teams
Company
Staftonic LLC
At Staftonic, we believe in turning possibilities into realities.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase