Qualification & Validation Engineer

2 weeks ago

Waterford, Waterford, Ireland itContracting Full time

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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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