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Senior Consultant- Commission & Qualification Engineer, Life Sciences - Business Consulting (Mo[...]
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monterrey, Mexico
Location
monterrey
Posted
June 27, 2026
Commute
Local Area
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Job Description
Senior Consultant – Commission & Qualification Engineer, Life Sciences
We are looking for senior‑level consultants experienced in Commissioning & Qualification Engineering within the Life Sciences domain.
Key Responsibilities- 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 specifications) and integrate them into the qualification process.
- Perform system risk assessments, GxP impact assessments, and 21 CFR Part 11 / Annex 11 evaluations.
- Computerized System Validation (CSV) – IT & OT Systems
- Execute CSV activities aligned with GAMP5 and company SOPs.
- Validate integrated systems such as LIMS, ELN, CDS, QMS/eQMS, MES, DCS, SCADA, PLC‑based systems, Building Management Systems (BMS/HVAC), and process equipment automation (CIP/SIP, reactors, isolators, autoc...