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Qualification & Validation Engineer, Waterford
Client:
itContracting
Location:
Waterford, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
3e33b59ad81b
Job Views:
9
Posted:
18.08.2025
Expiry Date:
02.10.2025
Job Description:
Overview
The Validation Engineer supports new product introductions, equipment qualification, and site requalification programs. This role ensures the ongoing validation and compliance of equipment, systems, and processes.
Job Responsibilities
* Design, execute, and report on PV/Process Performance Qualifications.
* Design, execute, and report on validation studies for equipment, systems, and processes.
* Manage validation studies in accordance with standards and legal requirements (Health & Safety, cGMP, etc.).
* Provide guidance on US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Ensure validation status complies with cGMP standards.
* Maintain validation documentation throughout the lifecycle.
* Participate in external regulatory inspections.
* Support Site Change Control processes.
Skills
* Troubleshoot validation issues related to projects and process development.
* Technical knowledge of pharmaceutical plants.
* Experience in validation/product development is advantageous.
* Knowledge of Process Validation regulations and industry practices.
* Understanding of GAMP, ISPE guides, and validation publications such as AAMI/ANSI, PDA, ISO.
* Knowledge of quality and compliance regulations.
* Ability to execute projects as planned.
* Good understanding of quality management systems.
* Strong communication skills.
* Experience with MS Project and SPC packages is a plus.
* Understanding of site KPIs.
If you would like to discuss this role in confidence, contact Harleen Tora.
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