QC Validation Engineer
Core
Manages non-testing systems and processes for Quality Control (QC), including new equipment qualification, requalification, and lifecycle management to ensure regulatory compliance.
Role type
QC Validation Engineer
Builds
Validated state for laboratory equipment, instruments, and computerized systems within a pharmaceutical manufacturing environment.
Domain
Biopharmaceuticals / Quality Control / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IQ/OQ/PQ protocol authoring and execution, GMP compliance, equipment lifecycle management, calibration, risk assessment, technical writing, data integrity practices
Preferred skills
LIMS/LES system familiarity, laboratory automation experience, cross-functional project leadership, audit preparation support
Technologies
LIMS, LES, instrument software, computerized laboratory systems
Responsibilities
Author and execute IQ/OQ/PQ protocols and reports for equipment and computerized systems; Perform PM/calibration/requalification of QC equipment including chambers and balances; Lead validation and lifecycle management of analytical instruments and laboratory computer systems; Support validation of computerized systems, access controls, and data integrity practices; Represent QC during regulatory audits; Collaborate with global teams to benchmark and optimize equipment usage across the network.
Seniority
Mid-level, hands-on IC