Position Overview
We are seeking an experienced Senior CQV / Lab Equipment Validation Engineerwith a minimum of 5 years' laboratory-based experienceto 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.
Key Responsibilities
* 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 11and 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, escalate 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.
Required Qualifications
* 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.
* Ability to work independently in a fast-paced, regulated environment.