Quality Engineer I, QA Systems
Core
Lead validation initiatives for manufacturing systems, equipment, and processes to ensure regulatory compliance and data integrity in healthcare manufacturing.
Role type
Senior IC Quality Engineer (Validation)
Builds
Validated manufacturing equipment, processes, cleaning, and computerized systems
Domain
Healthcare manufacturing / Pharmaceutical / Biotechnology
Required skills
Validation program execution, Protocol and report authoring, Statistical analysis, Change control management, Technical writing, Cross-functional collaboration, Regulatory compliance knowledge, Data integrity practices
Preferred skills
Liquid processing systems knowledge, Health Canada regulations expertise, TrackWise Change Management, Minitab/SPC, Six Sigma Green Belt, Root cause analysis, ERP systems
Technologies
TrackWise, Minitab, ERP systems
Responsibilities
Lead development and execution of validation programs for equipment and processes, Author validation protocols and reports, Partner with Engineering and Production to execute IQ/OQ/PQ, Provide technical guidance on data integrity and validation, Support change control and investigations, Participate in internal audits and regulatory inspections
Seniority
Mid-Senior, hands-on IC
