About the job
We are in search of a highly skilled Senior CQV / Lab Equipment Validation Engineer with at least 5 years of laboratory experience to contribute to a dynamic equipment installation and qualification project. This hands-on role encompasses the commissioning, qualification, validation, and documentation of laboratory instruments and systems. The ideal candidate should have the capability to work independently, effectively manage timelines, and produce high-quality validation packages that meet GMP, regulatory, and project specifications.
Key Responsibilities
Conduct commissioning, installation verification, IQ, OQ, and documentation for laboratory instruments and equipment.
Oversee validation activities to ensure adherence to GMP, GAMP5, Annex 11, 21 CFR Part 11, and internal quality standards.
Formulate, evaluate, and implement validation protocols, testing scripts, risk assessments, and summary reports.
Collaborate closely with Engineering, Lab IT, Quality Control, Quality Assurance, and external vendors to synchronize installation and qualification efforts.
Diagnose equipment issues, escalate technical challenges, and ensure prompt resolutions to maintain project schedules.
Guarantee all validation deliverables align with regulatory standards and audit criteria.
Keep meticulous records and ensure systems remain validated throughout their lifecycle.
Assist in managing change controls, deviations, investigations, and CAPA related to validation processes.
Work autonomously to handle workload and deliver assigned equipment qualification packages within strict deadlines.
