OT / Automation Engineer / Especialista en Sistemas de Automatización y Tecnología Operacional...

Location

Monterrey, CDMX, or Guadalajara (Hybrid, 3 days per week at Infosys Office)

Job Description

We are seeking a seasoned and highly specialized IT / OT Manufacturing Consultant to join our team. The ideal candidate will have deep domain expertise in the pharmaceutical manufacturing sector, focusing on the qualification and validation of Operational Technology (OT) and automation systems. This role requires on-site experience, a strong understanding of regulatory guidelines, and a proven ability to manage complex qualification processes.

Key Responsibilities

• Manage and execute the Application Qualification of Operational Technology (OT) systems in complex manufacturing environments.
• Lead the entire validation process, including writing, reviewing, and executing detailed test scripts for qualification.
• Qualify Process Automation Systems (PAS) and Distributed Control Systems (DCS) that are integrated with manufacturing equipment.
• Work directly on-site at manufacturing facilities to provide real-time support and ensure compliance with validation protocols.
• Collaborate with cross-functional teams to ensure adherence to internal Quality Management Systems (QMS) and external regulatory requirements.
• Monitor and troubleshoot system performance post-qualification, providing documentation for code, processes, and configurations.
• Mentor and guide junior team members on validation and qualification best practices.

Required Skills & Qualifications

Preferred Qualifications