Senior Consultant- Commission & Qualification Engineer, Life Sciences
We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Senior Consultant levels who are experienced in Commission and Qualification Engineer within Life Sciences domain.
Pharma IT & OT is responsible for lifecycle management, qualification, and documentation of GxP-regulated IT and OT systems used in pharmaceutical manufacturing, laboratories, utilities, and facilities.
The role also provides technical writing expertise to develop and maintain high quality validation, engineering, and system documentation aligned with regulatory expectations.
Key Responsibilities
1. Commissioning & Qualification (C\\&Q)
- Develop and execute commissioning plans and IQ/OQ/PQ protocols for IT, automation, OT, and digital systems.
- Review vendor documentation (URS, FAT/SAT, design specs) and integrate them into the qualification process.
- Perform system risk assessments, GxP impact assessments, and 21 CFR Part 11 / Annex 11 evaluations.
2. Computerized System Validation (CSV) – IT & OT Systems
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Execute CSV activities aligned with GAMP 5 and company SOPs.
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Validate integrated systems such as: LIMS, ELN, CDS, QMS / eQMS, MES, DCS, SCADA, PLC-based systems, Building Management Systems (BMS/HVAC)
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Process equipment automation (CIP/SIP, reactors, isolators, autoclaves, utilities)
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Create CSV deliverables: URS, FS, DS, configuration specs, RTM, validation summary reports.
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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.
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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.
3. Regulatory Compliance & Quality- Ensure compliance with:
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GxP, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity, ISPE/ISA guidelines
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Support audits, inspections, deviation resolution, CAPA, and change controls.
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Maintain documentation in validated repositories (e.g., Veeva, ValGenesis, Kneat)
4. Technical Writing & Documentation
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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
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Ensure document clarity, consistency, reuse, and compliance with pharma style guides.
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Collaborate with SMEs to convert technical concepts into structured documentation.
5. Project Execution & Stakeholder Collaboration
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Work closely with IT, Automation, Quality, Manufacturing, Engineering, and Vendors.
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Provide SME input during system design, vendor selection, FAT/SAT, and deployment.
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Track project milestones, risks, and validation deliverables.
6. Required Qualifications Educat
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Bachelor’s or Master’s in, Engineering (Instrumentation, Electrical, Electronics, Mechanical)/ Computer Science / IT/ Life Sciences / Pharmaceutical Technology Or related disciplines
7. Experience
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5 years of experience in C\\&Q, CSV, or OT in pharmaceutical or biotech environments.
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Hands on experience in validating automation/OT systems and GxP IT systems.
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Experience writing highly structured technical and validation documents.
8. Technical Skills Strong knowledge of:
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MES, LIMS, CDS, QMS, PLC/SCADA/DCS platforms (Siemens, Rockwell, Emerson, Honeywell), BMS/HVAC automation, OSI PI or similar historian
9. Proficient in creating:
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Validation docs (URS, FS, DS, IQ/OQ/PQ, RTM)
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Engineering drawings / network diagrams
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Technical manuals & SOPs
10. Soft Skills
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Excellent writing, communication, and documentation clarity.
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Detail oriented with a strong analytical mindset.
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Ability to work in global cross-functional teams.
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Strong organizational and time management skills.
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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
