Description
Senior Validation Engineer required for a contract opportunity working with a market leading Medical Device manufacturing organisation located in Ireland. Due to site expansion and improvement projects our client is looking for a Senior Validation Engineer to support the QA Validation team, playing a key role in the planning and execution of validation activities related to projects.The Senior Validation Specialist will input into all project phases from design through to the commissioning and qualification execution phases of the project and is critical to the start-up, license approval and the on-going sustaining of operations.
Responsibilities:
-Preparation of validation protocols to support site improvement projects.
-Resource for the support of CR`s (change requests), generation, review and approval of all associated documentation.
-Risk assessments of processes across all phases.
-Support a number of projects within a number of operational areas.
-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.
-Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
-Prepare reports of executed protocols for review by QA.
-Initiate and implement change control activities in accordance with site procedures.
-Track and resolve exceptions during qualification activities.
-Prioritize qualification activities in line with the project schedule.
-Co-ordinate qualification activities with engineering, construction and commissioning activities.
-Co-ordinate qualification activities with contractors and vendors as required.
-Co-ordinate qualification document review and approval.
Skills/Experience required:
* Degree qualified in a relevant subject
* Experience working within a Medical Device/Biotech/Pharmaceutical manufacturing environment
* Full validation life cycle experience is required