ALL KNOWN SERVICES · 1 day ago
Senior Validation Engineer
Hampton Roads, Virginia Metropolitan Area
Contract
Hybrid
Senior Level
$80/hr - $90/hr
5+ years expALL KNOWN SERVICES is seeking an experienced Senior Validation Engineer responsible for ensuring that equipment, processes, and analytical methods are properly validated in compliance with regulatory and quality standards. This role will support production operations by providing ongoing quality engineering support throughout the product lifecycle and conducting Non-Conformance (NC) and Out of Specification (OOS) investigations.
Staffing & Recruiting
Hiring Manager
John J
Responsibilities
Review and execute:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV) protocols, Analytical test methods
Serve as a hands-on Validation Lead for validation of changes to:
Existing processes, Systems, Equipment
Review equipment manuals, drawings, specifications, and operational documents to ensure alignment with:
Manufacturer specifications, Calibration requirements, Maintenance procedures
Perform and document:
Non-Conformance (NC) investigations, Out of Specification (OOS) investigations
Apply quality improvement methodologies:
Six Sigma, Statistical analysis tools, PFMEA (Process Failure Mode Effects Analysis), CAPA (Corrective & Preventive Action)
Support internal and external audits by explaining validation and qualification activities
Qualification
Required
Strong experience in writing technical documentation
Strong experience in writing analytical method requirements
Strong experience in writing validation protocols
Proven ability to lead validation activities and prioritize tasks
Strong understanding of quality systems and regulatory validation standards
Excellent written and verbal communication skills
Strong organizational and interpersonal skills
Ability to work effectively in cross-functional team environments
Bachelor of Science degree in Science, Engineering, or related field
5–7 years of validation or related experience
Equivalent combination of education and experience will be considered
Company
ALL KNOWN SERVICES
All Known Services is committed to redefining how organizations hire talent and build technology.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase