Position Overview
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.
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 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.
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.
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