Lead Engineer, Engineering - Validation
Core
Lead Validation activities for GMP Biotech manufacturing facility, covering facility, equipment, utilities, and computer systems from URS through PQ.
Role type
Lead Validation Engineer (GMP Biotech)
Builds
Validated state of manufacturing systems, utilities, and processes for medicine production
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP experience, validation methodologies, risk-based approaches for cleaning and sterilization, regulatory requirements understanding, engineering degree
Preferred skills
Kneat GX proficiency, Trackwise proficiency
Technologies
Kneat GX, Trackwise
Responsibilities
Lead or support validation activities for facility, equipment, utility, computer system, and sterilization; Develop and execute validation protocols and reports for temperature chambers, clean utilities, clean rooms, autoclaves, manufacturing equipment, and lab equipment; Investigate and resolve discrepancies and incidents arising from qualification activities; Review and approve validation protocols and reports including deviation investigations; Perform periodic reviews of the Site Validation Maintenance Program; Develop validation plans for change implementation projects; Coordinate with Engineering, End-User, and Quality teams; Review engineering documents for commissioning and validation; Evaluate and propose improvements to equipment, systems, processes, and operations; Review and assess Site Change Controls and Validation CAPAs; Participate in customer and agency audits and inspections; Provide training to validation staff
Seniority
Lead, hands-on IC
