ITOT Validation Consultant

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

• Bachelors 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.

• Good understanding of ISA95 standards and OT Security best practices.

Preferred Qualifications

• 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.