Description
An exciting contract opportunity has arisen for a Senior Validation Engineer to join a global Biopharmaceutical organisation based in one of their facilities in the South of Ireland.The successful Validation Engineer will be a member of the Technical Operations Validation team, playing a key role in the planning and execution of validation activities. The Validation Specialist will provide input into all aspects of validation i.e. from design through to the commissioning and qualification execution phases.
Primary Tasks and Responsibilities:
* Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements.
* Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
* Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
* Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
* Execute qualification protocols as required.
* Track and resolve exceptions during qualification activities.
* Co-ordinate qualification activities with engineering, construction and commissioning activities.
* Co-ordinate qualification document review and approval.
* Drive continuous improvement within the validation group
Background Experience:
* The person will have a proven track record in the qualification of any of the following systems:
* Qualification of SIP and autoclaves.
* Equipment Qualification
* Qualification of Clean Utilities.
* Qualification of HVAC (ISO classes 5 to 8).
* Qualification of Control Systems �¿ Emerson DeltaV, Honeywell Building Management Systems and Siemans PLCs.
* Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
* Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply cGMP regulations and guidelines to all aspects of qualification activities.
Education:
* A degree qualification in Science or Engineering