OT/Automation Engineer, Pharmaceuticals | Especialista en Sistemas de Automatización y Tecnolog[...]

Infosys Limited; Monterrey (Batáquez), Región Centro; Presencial; MXN 1,287,000 - 1,656,000; Jornada completa

Descripción de la vacante

A global IT services leader is seeking an experienced IT/OT Manufacturing Consultant to ensure compliance and manage qualification processes in the pharmaceutical manufacturing sector. Candidates should have extensive experience in IT/OT consulting, strong regulatory knowledge, and the ability to work on-site to provide real-time support. The position requires a Bachelor’s degree and a deep understanding of regulatory guidelines. This role offers a chance to work with cross-functional teams to navigate challenges and improve quality management systems.

Formación

• 6+ years of professional experience in IT/OT consulting or a related field.
• Strong understanding of IT Quality Management Systems (QMS).
• In-depth knowledge of regulatory guidelines like 21 CFR Part 11.

Responsabilidades

• Manage and execute Application Qualification of OT systems.
• Lead the validation process, including writing and executing test scripts.
• Troubleshoot system performance post-qualification.

Conocimientos

IT/OT consulting

Pharmaceutical manufacturing knowledge

Validation and qualification

Regulatory guidelines understanding

Problem-solving

Educación

Bachelor’s degree in Computer Science, Engineering, or a related field

Herramientas

Kneat

HP ALM

SNOW

Descripción del empleo

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

• 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.
• 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.

Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation.

Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.