Senior QA Validation Engineer
ROLE OVERVIEW
Provide quality oversight for equipment and system Commissioning, Qualification and Validation projects in
a GMP-regulated environment. The role works closely with Engineering, Validation, Manufacturing,
Automation, QC, and project teams to ensure systems are compliant, appropriately qualified, and suitable
for intended use.
KEY RESPONSIBILITIES
* Provide QA oversight throughout the commissioning, qualification, and validation lifecycle for equipment, facilities,
utilities, and associated systems.
* Review and approve validation plans, URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, traceability
documents, summary reports, and system-release packages.
* Ensure CQV execution follows approved procedures, predefined acceptance criteria, GMP expectations, and data
integrity requirements.
* Assess protocol discrepancies, deviations, test failures, and corrective actions; confirm appropriate resolution
before system release.
* Provide QA input to change controls, validation impact assessments, design changes, system modifications, and
requalification strategies.
* Review vendor and engineering documentation, turnover packages, calibration records, drawings, and supporting
evidence for completeness and traceability.
* Participate in project meetings, communicate compliance risks, and support timely closure of qualification
deliverables.
* Support final QA release and handover of qualified systems, inspection readiness, internal audits, and regulatory
inspections.
CANDIDATE REQUIREMENTS
* Degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Science, or a related discipline.
* Relevant QA, validation, commissioning, qualification, engineering, or project quality experience in a GMP-regulated
industry.
* Knowledge of the validation lifecycle and qualification principles for equipment, facilities, utilities, or automated
systems.
* Familiarity with URS, risk assessments, DQ, IQ, OQ, PQ, validation protocols, deviations, change control, and
summary reports.
* Strong technical review, documentation, problem-solving, communication, and stakeholder-management
capabilities.
CMC is an equal opportunity employer. We welcome applications from individuals of all ages and backgrounds and assess candidates solely on merit, skills, and potential. No terminology in this advert is intended to discriminate in any way.
We welcome applications/enquiries from individuals of all backgrounds and are committed to providing equal access to employment opportunities across all regions in which we operate.