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.

The Opportunity

Reporting to the Director of Facilities and Engineering, you will be a successful hands-on contributor to the build and start-up of Denali’s Utah manufacturing site. You will assist in the build of manufacturing and facility systems to support the delivery of Denali’s rapidly expanding large molecule pipeline. The Sr. Process Engineer will foster an environment that encourages Denali’s Core Values, innovation, and continuous improvement.

Responsibilities

  • Provide process engineering expertise to engineering firms, equipment vendors, and construction resources throughout all project phases (design through construction and startup)
  • Support vendor acceptance testing and startup validation activities for new equipment
  • Compile and maintain equipment requirements and design specifications
  • Support recipe authoring and technical content development for digital systems including training
  • Function as a process and technology subject matter expert providing on-the-floor technical support
  • Develop standard operating procedures while working with manufacturing processes and systems
  • Apply process engineering knowledge throughout the capitol project life cycle: basic design, detailed design, construction, commissioning, process validation, and manufacturing
  • Manage and provide expertise for process aspects of planned maintenance, project work and shutdown activities once plant is operational
  • Analyze data to support investigations, process monitoring, and optimization
  • Ability to work intermittent, on-call schedules as needed to support manufacturing
  • Partner with Quality to assess deviations, determine root cause and execute preventive and corrective actions

Basic Qualifications

  • Bachelor's degree in Chemical or Mechanical Engineering or appropriate engineering discipline
  • 10+ years of engineering related experience
  • 5+ years in BioPharma Industry experience
  • Ability to travel up to 10% by air and road
  • Physical – must be able to don specialized gowning, lift, ladder, stand, etc….

Preferred Qualifications

  • Clear technical experience in design and operation of utilities (WFI, HVAC) and bio-processing technologies (cell culture and purification), with experience with single use technologies
  • Experience in leading product/process support within a GMP manufacturing setting
  • Direct knowledge of FDA cGMP regulations/requirements for manufacturing clinical biopharmaceuticals
  • Extensive experience with GXP system implementation, procedures, and documentation
  • Demonstrated experience building and leading technical teams
  • Builds trustful and effective relationships
  • Confidence to lead through uncertainty in a rapidly changing environment
  • The ability to contribute to a team where employees have a shared purpose and vision; foster a “One Denali” environment
  • Strong self-awareness of the impact communication and working style has on others
  • Understands that authenticity and humility at work are the keys to building trust
  • Exceptional influencing, partnership, and collaboration skills across all levels
  • Excellent oral presentation and written communication skills

 

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.

 

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