C&Q Engineer
Core
Ensuring systems, facilities, and equipment meet design requirements for GMP-regulated facilities through commissioning, qualification, and validation.
Role type
Senior IC C&Q Engineer
Builds
GMP-compliant pharmaceutical and biotechnology facilities and equipment
Domain
Pharmaceutical manufacturing / Biotechnology / GMP-regulated environments
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based CQV approach, DQ/FAT/SAT/IQ/OQ/PQ/PV documentation, SOP development, temperature mapping of Controlled Temperature Chambers, benchtop autoclave qualification, digital validation platforms, project timeline management, regulatory compliance (cGMP)
Preferred skills
Experience with Kaye Validator or Testo systems, experience with Kneat digital validation platforms
Technologies
Kaye Validator, Testo, Kneat
Responsibilities
Plan and execute commissioning, qualification, and validation activities; Develop and review qualification protocols and validation reports; Collaborate with Engineering, Quality, Manufacturing, and Project teams; Manage project activities and timelines; Provide status reports to Project Managers
Seniority
Senior, hands-on IC
