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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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