HireDiversity

Limerick, IE

Validation Engineers X 3-000002X3

Description

Position Title: Validation Engineer

Department: Quality

Report to: Quality Business Unit Manager

Location: Limerick

Company Summary:

Vistakon Ireland is located in Limerick and produces the Acuvue range of contact lenses which is the leading contact lens product in the world. Our Limerick site uses the most advanced technology in the industry and we now employ over 640 people directly. Using our highly automated production process, we produce daily disposable contact lenses while utilizing state of the art technologies such as injection moulding, robotics, vision systems and sterilisation systems.

Vistakon Ireland was established in 1995 in the National Technology Park close to the University of Limerick. The facility was originally fitted with six advanced production lines to manufacture one daily disposable contact lens for the European and Japanese markets. Since then we have expanded a number of times and now have over 31 production lines manufacturing one-day, fortnightly, monthly and colour contact lenses which are shipped worldwide.

Each year, we have increased output because of the increase demand for our Acuvue lenses throughout the world Continued expansion of our product lines and extensive engineering and retrofit projects ensure that this growth is sustained well into the future.

Position Summary:

Reporting to the Quality Team Leader, the Validation Engineer will work with the pertinent groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades.

Main duties and responsibilities:
- Supporting the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations
- Work with all departments in ensuring operational effectiveness and developing products
- 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
- 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

Qualifications


Education and Experience:

- Minimum of degree qualification in relevant science and/or engineering discipline
- 5 yrs in a Validation function within a similar industry with strong knowledge of CSV/GAMP 4
- Have a strong working 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 and have a strong knowledge of 21CFR regulations Part 11.

Primary Location:Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Relocation: Eligible
No
Job Function: Validation