What are the responsibilities and job description for the Senior Validation Engineer – EMPQ position at Intellectt Inc?
Job Description: Senior Validation Engineer – EMPQ
Location: Onsite –Redmond/Seattle WA
Duration: 6-12 months
Start: Mid July 2026
Pay Rate: $45/hr-$52/hr on W2 (all inclusive)
Role Overview:
The Senior Validation Engineer will lead Environmental Monitoring Performance Qualification (EMPQ) activities for GMP manufacturing spaces. This role owns EMPQ strategy, protocol development, execution oversight, and final reporting, ensuring EM systems, microbiology support equipment, and associated data systems are fit for intended use and compliant with regulatory expectations.
Key Responsibilities:
Lead EMPQ planning, execution, and close-out for GMP cleanrooms and controlled environments
Author and approve EMPQ Validation Plans and Qualification Protocols (QPs)
Develop, review, and update environmental monitoring–related risk assessments
Provide technical oversight for EMPQ execution using:
Active air samplers
Portable and fixed particle counters
Viable and non-viable EM monitoring devices
Oversee validation readiness of microbiology support equipment, including:
Incubators (20–25°C, 30–35°C, CO₂ where applicable)
Biosafety cabinets (BSCs) and laminar flow hoods
Colony counters
Review and interpret EMPQ data, including trending, alert/action limits, and recovery expectations
Author Qualification Summary Reports and support QA review and approval
Ensure EMPQ activities align with FDA, EU GMP, ISO 14644, and internal quality standards
Interface with Validation, Quality, Facilities, Engineering, and Manufacturing stakeholders
Mentor junior validation staff during protocol execution activities
Required Qualifications:
8 years of GMP validation experience in biotech or pharmaceutical manufacturing
Demonstrated expertise in EMPQ protocol authoring, execution, and reporting
Strong understanding of environmental monitoring programs and cleanroom control strategies
Extensive experience with EM and microbiology-related QC equipment
Excellent technical writing and regulatory communication skills
Ability to work independently in fast-paced onsite GMP environments
Salary : $45 - $52