Senior Engineer, Validation

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

This role leads validation and commissioning for GMP equipment, utilities, and facilities, developing validation strategies and ensuring compliance with cGMP and FDA regulations. Responsibilities include coordinating commissioning (IQ/OQ/PQ), collaborating with cross-functional teams, conducting risk assessments, and driving continuous improvement to maintain optimal product quality and operational excellence.

Key Accountabilities/ Core Job Responsibilities:

• Develop and implement robust validation strategies aligning with regulatory requirements.
• Oversee commissioning and qualification (C&Q) for GMP equipment, utilities, and facility systems.
• Manage change control procedures to ensure thorough evaluation and consistent documentation.
• Support CAPA initiatives, investigating root causes and implementing effective corrective actions.
• Draft and revise SOPs, ensuring compliance with cGMP guidelines and quality standards.
• Maintain accurate engineering drawings, ensuring proper control and up-to-date documentation.
• Coordinate with cross-functional teams to align validation projects and operational goals.
• Conduct risk assessments and implement improvements to enhance compliance and process efficiency.
• Train and mentor staff, fostering continuous improvement within the team.
• Stay current with evolving regulatory guidelines (FDA, EMA, ICH) and industry trends, recommending and driving enhancements to validation processes and documentation practices.

Qualifications/Skills:

• Minimum of a Bachelor's Degree in Engineering or related technical discipline with 7+ years of experience or a Master's Degree 5+ years of experience.
• Biopharma or related medical manufacturing industry experience preferred
• Experience using MasterControl is preferred
• Ability to work in a rapidly changing environment
• Ability to contribute to a team where employees have a shared purpose and vision; foster a "One Denali" environment
• Ability to collaborate and build trustful and effective relationships
• Proficient oral presentation and written communication skills

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.