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Senior Lab Equipment Validation Engineer

On-site Full-time

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Experience Level

Senior

Qualifications

Required QualificationsBachelor's or Master's degree in Engineering, Analytical Science, Chemistry, Biotechnology, Pharmacy, or a related field. A minimum of 5 years of experience in laboratory environments, particularly in CQV, Lab IT, instrument qualification, or analytical equipment validation. Proven track record with a diverse range of laboratory instruments, including HPLC, GC, balances, spectrophotometers, centrifuges, incubators, freezers, stability chambers, etc. Strong understanding of the qualification lifecycle (URS, RA, IQ/OQ, traceability, summary reports). Hands-on experience in equipment installation, commissioning, and validation. Knowledge of data integrity requirements, computerized system validation, and laboratory workflows. Experience working with vendors and cross-functional teams. Exceptional technical writing, documentation, and problem-solving skills.

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.

About Westbourne IT Global Services

Westbourne IT Global Services is a forward-thinking organization dedicated to providing innovative solutions in technology and engineering. We pride ourselves on our commitment to excellence and our ability to adapt to the ever-changing landscape of the industry. Join us and be part of a team that values creativity, integrity, and collaboration.

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