2023-2001-Validation Engineer-Waterford Contractor

Purpose:

The Validation Engineer has a key role in ensuring the ongoing Qualification and Validation compliance of equipment, systems, and processes.

Responsibilities:

• Integrally involved in the validation of all new equipment, processes, and control systems.
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, and computerised systems.
• Participates in the change control process advising on validation issues, as appropriate.
• Hands-on role in the development and execution of DQ, IQ, OQ CQV activities.
• Designs implements and executes validation studies for manufacturing and control equipment.
• Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing, and sterilisation.
• Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
• Maintain validation documentation through the – Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
• Generate/review/approve execution of Protocols
• Review and approval of site change controls.

Requirements:

• 3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
• 2-3 years’ experience in validation environment.
• Good Understanding of DATA Migration
• Good Understanding of Data Integrity Requirements
• Good Understanding of control system validation and IT system Validation
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Able to execute projects to plan.
• Good knowledge of quality management systems.
• Good communication skills at organisation, team and individual levels.
• Ability to use MS Project and SPC packages an advantage.