Senior Consultant- Commission & Qualification Engineer, Life Sciences - Business Consulting (Mo[...]

We are looking for senior‑level consultants experienced in Commissioning & Qualification Engineering within the Life Sciences domain.

• 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...