Senior Automation Engineer

Denali Therapeutics•Salt Lake City, UT

53d

About The Position

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 integration of equipment and digital systems, overseeing process control, e-batch records, and building management. Responsibilities include collaborating with cross-functional teams, directing vendors, programming automation equipment, maintaining IT/OT infrastructure, and ensuring GMP compliance. The role also develops SOPs, implements improvements, investigates deviations, and manages data for optimized performance.

Requirements

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
Extensive experience in leading product processing equipment support following FDA cGMP regulation requirements manufacturing setting.
Extensive experience deploying and supporting digital systems for manufacturing support including IT/OT interface, PLC programming
Ability to work intermittent, on-call schedules as needed to support manufacturing
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

Responsibilities

Lead the design and implementation of automation strategies encompassing process control, supervisory control, automation recipes, and building management systems.
Support building and manufacturing equipment, integrating automation and business systems to enhance efficiency and reliability.
Collaborate with manufacturing teams and end-users, implementing system improvements, providing training, and driving operational efficiencies.
Provide technical direction to engineering firms, vendors, and contractors, overseeing acceptance testing, startup validation, and project execution.
Develop SOPs, author recipes, and create technical documentation for automation and digital systems, ensuring compliance with regulatory standards.
Partner with Quality to investigate deviations, perform root-cause analyses, and execute corrective/preventive actions in alignment with GMP requirements.
Establish and maintain IT relationships, addressing network issues, managing data historians, and integrating automation with business systems.
Oversee IT/OT infrastructure maintenance and management, collaborating with cross-functional teams to minimize downtime and optimize performance.
Program automation equipment, refine control logic, and maintain recipes, ensuring seamless operation and adherence to process requirements.
Revise and maintain network drawings, capturing system upgrades, ensuring accurate documentation, and facilitating future modifications.