Senior Quality Validation Engineer (12-month Term)

Denali Therapeutics • Salt Lake City, UT

5d

About The Position

Denali Therapeutics is a biotechnology company focused on developing breakthrough therapies for neurodegenerative diseases. We are seeking a detail-oriented and experienced Senior Quality Validation Engineer to support biologics manufacturing operations. This role will focus on enhancing and maintaining quality oversight and compliance systems for validation activities. The position will also support and coordinate day-to-day activities related to system and software validations, onboarding new equipment, and routine facility, utility, and equipment calibration and maintenance programs.

Requirements

• Typically requires a Bachelor’s degree in life science, biology, biotechnology, or a related scientific discipline and 8+ years of work experience, including 5+ years in QA or QC within a biologics or pharmaceutical manufacturing environment.
• Previous experience working in a GMP regulated facility with focus on GMP validation activities such as generation, execution and approvals
• Familiarity with different types of validation such as laboratory and manufacturing equipment, facility and utility cleanroom systems, validation documents, and vendor qualification and validation requirements
• In depth understanding of cGMP, FDA, and EU regulatory requirements.
• Excellent communication, documentation, and organizational skills.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Familiar with Master Control, Blue Mountain and Kneat applications

Responsibilities

• Review GMP validation documentation for Risk Assessment, System Classification, URS, IOQ, PQ protocols and reports and calibration and maintenance documentation
• Collaborate cross-functionally—including Process Dev, QC, Manufacturing, and Validation—to support capital projects, scale‑up, tech transfer, and inspection readiness
• Represent Quality for validation activities generated on the site or impactful to the site
• Support computer system validation policies and overall strategies and ensure compliance and consistency with regulatory requirements and best industry practices
• Provide quality input on the development of validation policies, procedures, standards and templates
• Review and approve technical documents throughout the equipment/system lifecycle from commissioning, qualification and/or validation through decommissioning, including validation plans, risk assessments, test protocols and reports
• Provide input into validation and testing strategies based on system risk, complexity, and other relevant factors and ensure all validated systems and documentation comply with applicable regulatory requirements
• Support other Quality Operation activities such as on the floor presence, material disposition and deviation/capa management

Benefits

• 401k
• healthcare coverage
• ESPP
• a broad range of other benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior