ITOT Validation Consultant
ITOT Validation Consultant
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Salary Not Disclosed
1 Vacancy
Job Description
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.
About Us
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. With over four decades of experience in managing the systems and workings of global enterprises we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills expertise and ideas from our innovation ecosystem.
EEO
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. 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.
Required Experience:
Contract
Employment Type
Full Time
