Large Scale mAbs Automation Lead

What you'll do

• Develop and implement a comprehensive manufacturing systems strategy for the new Large Scale mAbs facility.
• Serve as the automation subject matter expert during the Basis of Design and detailed design phases.
• Create detailed project plans outlining schedules, resource allocation, milestones, and deliverables for automation systems.
• Integrate automation systems with digital applications to ensure connectivity between production, quality control, and data management.
• Oversee external system integrators and coordinate with procurement to select vendors meeting regulatory standards.
• Lead code reviews, Factory Acceptance Tests (FATs), and Site Acceptance Tests (SATs) for automation software and hardware.
• Partner with the CQV team to execute automation validation strategies and manage change controls.
• Deploy the Next Generation IIoT Platform and ensure all systems adhere to Cyber by Design principles.

What we're looking for

• Bachelor's degree in Engineering, Automation, Computer Science, Biotechnology, Pharmaceutical Sciences, or any field.
• 8+ years' experience in automation engineering within the pharmaceutical industry (preferred).
• 3+ years in a leadership or project lead role (preferred).
• Proven track record in managing complex manufacturing systems involving automation, robotics, and advanced technologies (preferred).
• Experience in multi-site operations, global projects, and matrix management (preferred).
• Thorough knowledge of cGMP and regulatory requirements (preferred).
• Proficiency in Process Control Systems (DeltaV), Industrial Application Platform (Ignition), PLCs (Rockwell), and other automation technologies (preferred).
• Systems engineering mindset with ability to design and implement robust system integration architectures (preferred).