LS SCON Commission & Qualification Engineer) MX- Business Consulting

• Execute CSV activities aligned with GAMP 5 and company SOPs.
• Validate integrated systems such as: LIMS ELN CDS QMS / eQMS MES DCS SCADA PLC-based systems Building Management Systems (BMS/HVAC)
• Process equipment automation (CIP/SIP reactors isolators autoclaves utilities)
• Create CSV deliverables: URS FS DS configuration specs RTM validation summary reports.
• Operational Technology (OT) Lifecycle Management
  Support OT system engineering and qualification in manufacturing and utilities areas.
• Ensure OT systems follow secure architecture backup/restore disaster recovery and change management processes.
• Collaborate with automation engineers on: SCADA PLC logic changes DCS recipes historian systems (OSI PI AVEVA etc.)
• Implement and maintain data integrity controls in OT systems.

• GxP 21 CFR Part 11 EU Annex 11 ALCOA data integrity ISPE/ISA guidelines
• Support audits inspections deviation resolution CAPA and change controls.
• Maintain documentation in validated repositories (e.g. Veeva ValGenesis Kneat)

• Create high-quality audit ready documents including: SOPs work instructions user manuals Validation & qualification protocols Engineering documentation (network diagrams system architecture) Technical specifications test scripts installation guides
• Ensure document clarity consistency reuse and compliance with pharma style guides.
• Collaborate with SMEs to convert technical concepts into structured documentation.

• Work closely with IT Automation Quality Manufacturing Engineering and Vendors.
• Provide SME input during system design vendor selection FAT/SAT and deployment.
• Track project milestones risks and validation deliverables.

• Bachelors or Masters in Engineering (Instrumentation Electrical Electronics Mechanical)/ Computer Science / IT/ Life Sciences / Pharmaceutical Technology Or related disciplines

• 5 years of experience in C&Q CSV or OT in pharmaceutical or biotech environments.
• Hands on experience in validating automation/OT systems and GxP IT systems.
• Experience writing highly structured technical and validation documents.

• MES LIMS CDS QMS PLC/SCADA/DCS platforms (Siemens Rockwell Emerson Honeywell) BMS/HVAC automation OSI PI or similar historian

• Validation docs (URS FS DS IQ/OQ/PQ RTM)
• Engineering drawings / network diagrams
• Technical manuals & SOPs

• Excellent writing communication and documentation clarity.
• Detail oriented with a strong analytical mindset.
• Ability to work in global cross-functional teams.
• Strong organizational and time management skills.
• Candidates authorized to work for any employer in Mexico without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time

About Us
Infosys Consulting is the global management and technology consulting practice of Infosys a global leader in technology services and consulting. We combine the power of time-tested methodologies people-driven innovation and disruptive technology to enable leaders of the worlds top brands pursue a path of smart transformation. Together with our clients internal and external partners we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants:
Ability to design and implement end-to-end solutions at scale
A flat organization structure with direct access to our senior-most leaders
An entrepreneurial environment full of bright highly motivated consultants
Opportunities for motivated consultants to impact local communities
The ability to design your career and drive your professional learning and development
A truly global culture

EEO
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