Senior Process Engineer

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 new equipment procurement, ensures process performance integrity, and maintains compliance with FDA GMP requirements. Responsibilities include managing Engineering Change Orders, refining equipment documentation, minimizing downtime via spare parts strategies, coordinating site upgrades, revising P&IDs, conducting risk assessments, and training teams for continuous improvement across the manufacturing workflow.

Key Accountabilities/ Core Job Responsibilities:

• Lead production equipment procurement efforts, from vendor selection through installation and qualification, in alignment with FDA GMP requirements.

• Manage Engineering Change Orders (ECOs), ensuring thorough review, proper documentation, and timely implementation of equipment-related modifications.

• Maintain accurate equipment master data, updating technical specifications and operational details for compliance and audit readiness.

• Evaluate and define suitable spare parts substitutes, minimizing equipment downtime and optimizing inventory management.

• Lead site upgrades and buildout activities, collaborating with internal cross-functional teams and contractors to ensure minimal operational disruption and adherence to GMP regulations.

• Develop equipment modification designs, partnering with suppliers and internal stakeholders to enhance process efficiency and product quality.

• Revise P&IDs and equipment drawings, maintaining accurate documentation that reflects current operating conditions and regulatory requirements.

• Conduct risk assessments and gap analyses on new or modified equipment, recommending mitigation strategies that uphold product integrity.

• Provide expert guidance and training to cross-functional teams, fostering continuous improvement and robust engineering practices in a GMP environment and corrective actions

Qualifications/Skills:

• Bachelor's degree or advanced degree in Engineering or appropriate technical discipline

• 8+ years of engineering related experience with Bachelor's Degree and 6+ years with an Master's degree, or 3+ years with a PhD

• BioPharm Industry experience preferred

• Ability to travel up to 10% by air and road

• Demonstrated experience collaborating within technical teams

• Builds trustful and effective relationships with authenticity and humility.

• 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.

• Exceptional influencing, partnership, and collaboration skills across all levels.

• Excellent oral presentation and written communication skills

• Physical requirements- must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time

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.

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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