QA Validation Engineer
CagentsIrelandFull Time1w ago
EngineeringQAremotecurated-jd
Job description
QA Validation Engineer at Cagents.
About the role
Cagents is hiring a QA Validation Engineer to manage qualification and validation tasks for process and lab equipment. You will work onsite at major pharmaceutical and biotech facilities throughout Ireland to ensure all systems meet strict regulatory standards.
Key facts
What you'll do
- Run IQ, OQ, and PQ procedures for GMP-regulated systems.
- Draft and audit validation reports, protocols, and lifecycle files.
- Oversee commissioning, qualification, and validation projects from the initial plan to final execution.
- Manage risk assessments, CAPA, change control, and deviation processes.
- Maintain adherence to GDP and GMP standards.
- Assist with audit preparations and inspection readiness.
- Drive equipment lifecycle management and process improvement tasks.
Requirements
- Degree in Science, Engineering, Biotechnology, or a related field.
- Minimum of 3 years of experience in validation within the medical device, biotech, life sciences, or pharmaceutical sectors.
- Background in qualifying manufacturing or laboratory equipment in GMP environments.
- Proficiency in writing and running validation documentation.
- Knowledge of change control, deviation management, and CAPA workflows.
- Ability to manage stakeholders and communicate technical information clearly.
- Must hold legal authorization to work in Ireland.
Skills & tools
- GMP and GDP compliance
- IQ, OQ, PQ execution
- Technical writing
- Risk assessment
- Lifecycle documentation
Practical notes
- This role includes a competitive salary and benefits package.
- You will gain exposure to diverse CQV projects across the Irish life sciences sector.