Spark Life Solutions Inc · 11 hours ago
Equipment Validation Engineer – Periodic Review
Vancouver, WA
Contract
Onsite
Senior Level
5+ years expSpark Life Solutions Inc is seeking an experienced Equipment Validation Engineer to support GMP equipment periodic reviews and requalification activities at a large-scale manufacturing site in preparation for an upcoming FDA Pre-Approval Inspection. The engineer will evaluate existing validation and quality documentation, identify compliance gaps, and make risk-based recommendations, focusing on assessment and documentation rather than protocol execution.
Staffing & Recruiting
Hiring Manager
M D Shanawaz
Responsibilities
Perform GMP equipment periodic reviews for manufacturing and support equipment
Review and assess:
Equipment validation packages
Change controls
Risk assessments
Historical deviations and CAPAs
Identify compliance gaps and determine whether issues:
Are acceptable as-is, or
Require deviation initiation
Clearly document findings, rationale, and recommendations
Support onsite field testing when required (escorted visits)
Work efficiently to meet aggressive regulatory timelines supporting FDA readiness
Qualification
Required
5+ years of experience in GMP equipment validation/qualification
Strong hands-on experience with equipment periodic reviews
Strong hands-on experience with equipment requalification
Strong hands-on experience with change control impact assessments
Strong hands-on experience with risk-based decision making
Ability to make clear go / no-go compliance decisions
Preferred
Prior experience supporting FDA inspections or PAIs
Quality background (QA, Compliance, Audits)
Experience with deviation initiation and documentation
Validation assessments
Cross-functional collaboration with CSV and CQV teams
Familiarity working with large equipment asset portfolios
Company
Spark Life Solutions Inc
Welcome to a partnership focused on excellence.
51-200 employees
H1B Sponsorship
Spark Life Solutions Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (7)
Funding
Current Stage
Growth StageCompany data provided by crunchbase