Lab Equipment Validation Engineer

We are seeking an experienced Senior CQV / Lab Equipment Validation Engineer with a minimum of 5 years’ laboratory-based experience to support a fast-paced equipment installation and qualification project. The role involves hands‑on commissioning, qualification, validation, and documentation of laboratory instruments and systems. This engineer must be capable of working independently, managing timelines, and delivering high‑quality validation packages to meet GMP, regulatory, and project requirements.

• Perform commissioning, installation verification, IQ, OQ, and documentation for laboratory instruments and equipment.

• Lead validation activities ensuring compliance with GMP, GAMP5, Annex 11, 21 CFR Part 11 and internal quality procedures.

• Develop, review, and execute validation protocols, test scripts, risk assessments, and summary reports.

• Collaborate closely with Engineering, Lab IT, Quality Control, Quality Assurance, and external vendors to coordinate installation and qualification tasks.

• Troubleshoot equipment, escalates technical issues, and ensure timely resolution to maintain project timelines.

• Ensure all validation deliverables meet regulatory expectations and audit standards.

• Maintain accurate records and ensure systems remain in a validated state throughout their lifecycle.

• Support change controls, deviations, investigations, and CAPA related to validation activities.

• Work independently to manage workload and deliver assigned equipment qualification packages within tight deadlines.

• Bachelor’s or Master’s degree in Engineering, Analytical Science, Chemistry, Biotechnology, Pharmacy, or related discipline.

• Minimum 5+ years’ experience in laboratory-based roles, specifically in CQV, Lab IT, instrument qualification, or analytical equipment validation.

• Demonstrated experience with a wide range of lab instruments, such as (HPLC, GC, balances, spectrophotometers, centrifuges, incubators, freezers, stability chambers, etc.).

• Strong understanding of qualification lifecycle (URS, RA, IQ/OQ, traceability, summary reports).

• Hands‑on experience supporting equipment installation, commissioning, and validation.

• Familiarity with data integrity requirements, computerized system validation, and laboratory workflows.

• Experience liaising with vendors and cross‑functional stakeholders.

• Strong technical writing, documentation, and problem‑solving skills. xcfaprz

• Ability to work independently in a fast‑paced, regulated environment.