Senior Quality Validation Engineer (12-month Term)
Denali Therapeutics
8 hours ago
On-site
Salt Lake City, UT
Operations
Senior Quality Validation Engineer — Responsibilities
- Review GMP validation documentation (Risk Assessment, System Classification, URS, IOQ, PQ protocols/reports, calibration and maintenance).
- Collaborate cross-functionally (Process Dev, QC, Manufacturing, Validation) to support capital projects, scale-up, tech transfer, and inspection readiness.
- Represent Quality for site validation activities.
- Support computer system validation policies/strategies to ensure compliance and consistency with regulatory requirements and best practices.
- Provide quality input to validation policies/procedures/standards/templates.
- Review/approve technical documents across the equipment/system lifecycle (commissioning through qualification/validation to decommissioning), including validation plans, risk assessments, test protocols and reports.
- Develop validation/testing strategy input based on system risk/complexity and ensure regulatory compliance.
- Support Quality Operations (on-floor presence, material disposition, deviation/CAPA management).
Qualifications/Skills
- Bachelor’s in life science/biology/biotech or related field + 8+ years’ experience; 5+ years in QA/QC in biologics/pharmaceutical manufacturing.
- GMP-regulated facility experience with GMP validation (generation, execution, approvals).
- Familiarity with validation for laboratory/manufacturing equipment, facility/utility cleanroom systems; validation documents; vendor qualification/validation.
- In-depth cGMP, FDA, and EU regulatory knowledge.
- Strong communication/documentation/organizational skills; independent and cross-functional collaboration.
- Familiar with Master Control, Blue Mountain, and Kneat.
Benefits/Application
- Competitive total rewards: 401(k), healthcare coverage, ESPP, and other benefits. Learn more: https://www.denalitherapeutics.com/careers
- Review GMP validation documentation (Risk Assessment, System Classification, URS, IOQ, PQ protocols/reports, calibration and maintenance).
- Collaborate cross-functionally (Process Dev, QC, Manufacturing, Validation) to support capital projects, scale-up, tech transfer, and inspection readiness.
- Represent Quality for site validation activities.
- Support computer system validation policies/strategies to ensure compliance and consistency with regulatory requirements and best practices.
- Provide quality input to validation policies/procedures/standards/templates.
- Review/approve technical documents across the equipment/system lifecycle (commissioning through qualification/validation to decommissioning), including validation plans, risk assessments, test protocols and reports.
- Develop validation/testing strategy input based on system risk/complexity and ensure regulatory compliance.
- Support Quality Operations (on-floor presence, material disposition, deviation/CAPA management).
Qualifications/Skills
- Bachelor’s in life science/biology/biotech or related field + 8+ years’ experience; 5+ years in QA/QC in biologics/pharmaceutical manufacturing.
- GMP-regulated facility experience with GMP validation (generation, execution, approvals).
- Familiarity with validation for laboratory/manufacturing equipment, facility/utility cleanroom systems; validation documents; vendor qualification/validation.
- In-depth cGMP, FDA, and EU regulatory knowledge.
- Strong communication/documentation/organizational skills; independent and cross-functional collaboration.
- Familiar with Master Control, Blue Mountain, and Kneat.
Benefits/Application
- Competitive total rewards: 401(k), healthcare coverage, ESPP, and other benefits. Learn more: https://www.denalitherapeutics.com/careers