Senior Automation Engineer

Role Summary

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.

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.

Qualifications

• 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 a 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

Additional Requirements

• 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