Quality Validation Engineer
United States of America
Contract
1 week ago
H1B Sponsor Likely
Key skills
Validation documentationInstallation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Test Method Validation (TMV)Validation summariesValidation strategy developmentQuality systems knowledgeRegulated environmentsDeviation trackingCorrective and Preventive Actions (CAPA)Change controlValidation data reviewAudit readinessInspection supportValidation principlesManufacturing Practice (GMP)Documentation Practice (GDP)Pharmaceutical validationBiotech validationMedical device validationValidation protocolsComputer system validationCleaning validationProcess validationFDA requirementsISO requirementsGxP requirementsElectronic quality management systems
About this role
Fusion Life Sciences Technologies LLC is seeking a Quality Validation Engineer to support validation lifecycle activities across various systems. The ideal candidate will be responsible for authoring and executing validation documentation while collaborating with multiple teams to ensure compliance with quality standards.
Responsibilities:
- Author, review, and execute validation documentation including IQ, OQ, PQ, TMVs, and validation summaries
- Support validation strategy development for new and existing systems
- Collaborate with quality, manufacturing, engineering, and regulatory teams to ensure validation deliverables are aligned with compliance requirements
- Track deviations, CAPAs, and change controls related to validation activities
- Review validation data for completeness, accuracy, and traceability
- Assist with audit readiness and inspection support as needed
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or related field
- 3+ years of validation experience in pharmaceutical, biotech, or medical device environments
- Strong knowledge of GMP, GDP, and validation principles
- Experience writing and executing validation protocols independently
- Strong organizational skills and attention to detail
- Experience with computer system validation, cleaning validation, or process validation
- Familiarity with FDA, ISO, and GxP requirements
- Experience using electronic quality management systems