OT/Automation Engineer, Pharmaceuticals | 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.
  

• Bachelor's degree in Computer Science, Engineering, or a related technical field.
  
• 6+ years of professional experience in IT/OT consulting or a related field.
  
• Extensive professional experience with manufacturing domain knowledge, specifically in the pharmaceutical industry.
  
• Strong understanding of IT Quality Management Systems (QMS), validation, qualification, and risk management principles.
  
• In-depth knowledge of regulatory guidelines, including 21 CFR Part 11, EU Annex 11, and GAMP5.
  
• Hands-on experience with validation and quality management tools, including Kneat, HP ALM, and SNOW.
  
• Proven ability to handle application qualification for complex or specialty manufacturing processes.

• Experience with OT system qualification for critical dosage forms, such as Radioligand Therapy.
  
• Familiarity with DCS/PAS qualification processes.
  
• Previous experience in a client-facing or consulting role.