SOFTWARE VALIDATION ENGINEER - Tipperary
This is an excellent opportunity in a leading medical device organisation in Tipperary for a Senior Validation Engineer to drive projects and further develop their experience within a highly regulated manufacturing facility.
Job Description:
Responsible for implementing company software (IT controls) validation program. Responsible for driving and completing software and non-software validation projects and for oversight of elements of the validation program on site. Creates and maintains validation documentation for new and existing systems and processes subject to design control. 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.
Roles / Responsibilities:
- Represent co. during audits of validation projects and documentation.
- Write 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 directs, in assurance of timely and cost efficient completion through specialized experience and training
- Consult with user groups to summarize validation results in final reports incorporating strong communication skills and experience
- Manage Validation Master Plans and associated reports related to npd and existing production processes, systems, and controls
- Perform validation checks on Change Management documents including, but not limited to document changes, system changes, process change
- Track and report validation progress of corporate validation projects through dept tracking tools
Skills / Experience:
Degree essential with no less than 6 years relevant experience within Software Validation
A proven track record in working within a regulated pharmaceutical / medical device organisation required.
Strong Project Management skills required
An excellent remuneration is on offer to the successful candidate.
To appliy for this opportunity please forward your cv to Martin O'Leary in Brunel - moleary@brunel.ie or call me on 051 309652.