Senior consultant- commission (monterrey)

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, Gx P 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/e QMS, MES, DCS, SCADA, PLC‑based systems, Building Management Systems (BMS/HVAC), and process equipment automation (CIP/SIP, reactors, isolators, autoclaves, utilities). Create CSV deliverables: URS, FS, DS, configuration specifica...