Lab CSV Engineer

A global biopharmaceutical company is seeking a highly compliant IT Lab CSV Engineer for a 12-month hourly rate contract.

This role drives the technical design and compliant operation of critical laboratory instruments, collaborating closely with QA, QC, and CSV teams.

Key Responsibilities

• Ensure strict compliance for all Lab IT equipment (e.g., 21 CFR Part 11, EU Annexe 11, cGMP/GLP).
• Lead the introduction and technical setup of new analytical instrument systems.
• Manage equipment lifecycle from delivery to final commissioning and qualification.
• Act as a technical bridge between IT, Quality, and external vendors.

Required Profile

• 4+ years of specific IT experience in a GMP/Pharmaceutical laboratory environment.
• Degree in Engineering, IT, or Life Sciences.
• Strong knowledge of IT infrastructure: Active Directory, Group Policy, and Networking.
• Familiarity with systems like Solovpe, FIT, Osm, and Raman.
• Proven ability to work independently, demonstrate leadership, and apply critical thinking skills.