Senior Validation Engineer - Contract
|Job Title:||Senior Validation Engineer - Contract|
|Job Published:||about 2 months ago|
Contact: Caroline Kingston
Telephone: 086 8395533
Senior Validation Engineer - Contract
Our client, a medical device company in Limerick are currently looking to recruit a Senior Validation Engineer for their site on a contract basis.
Support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations
Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions.
Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.
Implement policies and procedures.
Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
Runs /Manages complaint investigation and resolution of same
Designs and develops validation documentation to support business continuity, new process introductions
Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Education and Experience
Bachelors degree from accredited college
3/5 yrs in a Quality function within the Medical Device/ Pharmaceutical industry.
Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
Ability to demonstrate standards of leadership – Managing Complexity/Credo Values/Innovations/Customer focus.
Good Influencing Skills
Project Management Skills
Good communication skills
Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets.
Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Lead by example, inculcating the Credo values in all actions within the workplace
Knowledge of bespoke validation. Process knowledge and documentation.
In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
Working experience of validation computer systems for use in a FDA regulated environment.
Must be able to lead and give direction to Validation Projects and Teams.
Individual must also be an active team member in Validation activities
A degree in an appropriate discipline (e.g. Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
For further information on this Senior Project Manager role in Limerick please contact Caroline Kingston 086 8395533/ firstname.lastname@example.org
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