Validation Engineer

Summary:
Our client is a bio pharmaceutical company based in South Dublin and is looking for a Validation Engineer who will be responsible for the implementation of the the commissioning and qualification of new/modified clean utilities and non GMP utilities and controlled environmental devices site wide. The job holder will provide technical expertise to ensure that systems and equipment are installed, commissioned and qualified to our client’s and regulatory specifications.

Responsibilities:

• Generate, review and approve documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
• Implement system change controls and ECM’s.
• Participate in design review for new/ modified utility systems.
• Participate in construction system mechanical completion walkdowns.
• Perform execution of CTPs, IQ, OQ, PQ Protocols in field.
• Perform execution of temperature mapping of equipment.
• Perform pre and post study calibration verifications.
• Operate according to SOPs developed for validation, validated manufacturing operations and cGMP compliance.
• Develop and implement changes required to resolve deviations/ events effectively.

Qualifications & Experience:

• B.Sc/B.Eng. degree in engineering discipline, with particular emphasis on mechanical or process engineering.
• Minimum of 3 years’ experience from biotechnology or pharmaceutical GMP manufacturing environment.
• Experience in temperature mapping with lives xpertval system is an advantage.
• Experience with qualification of clean utilities or HVAC is an advantage.
• Experience in good documentation practice.
• Experience in reading/verifying P&IDs.