Description
My client, a global health care company, is currently recruiting for the role of Validation Engineer at one of their facilities in the South East of Ireland. At this facility, the successful candidate will get the opportunity to work with one of the worlds leading manufacturers of drug eluting vascular stents. The successful candidate will be responsible for creating and implementing the companies' validation program, as well as create and maintain validation documentation for new and existing systems and processes subject to design control. They will also ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.Responsibilities
- Represent the company during internal and external audits of validation projects and documentation
- Write validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills
- Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion through specialized experience and training
- Evaluate validation results of validation protocol executions employing specialized experience and training
- Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience
- Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls
- Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes
- Track and report validation progress of corporate validation projects through departmental project tracking tools
Job Skills
- General understanding of business unit/group function
- Exercise judgment within defined procedures and practices to determine appropriate action
- Capable of cultivating a wide range of internal networks and begin to develop an extensive external network of resources to facilitate the completion of tasks
- Be able to plan, organize, and prioritize their own daily work routine to meet established schedule
Education/Experience
- Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or a Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience
To apply for this role apply directly to this advert or contact Derek Sheridan on for further details
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