HireDiversity

Limerick, IE

Software Quality Engineer-000003SR

Description

Position Title: Software Quality Engineer

Department: Quality

Report to: Quality 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.

Main duties and responsibilities:
- Co-ordination, implementation and active participation in the site validation programme for computer systems, automated product/process systems and lab systems.
- Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
- Develop validation documentation as required (e.g. specifications, plans, protocols, procedures etc.).
- 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
- Prioritize qualification activities in line with the project schedules and business needs.
- Prepare reports of executed protocols
- Resolve and assist in the closure of deviations initiated during qualification execution
- Initiate and implement change control activities in accordance with site procedures.
- Co-ordinate re-validation activities
- Generate SOP's / other documentation as applicable
- Conduct training in validation methodologies and related procedures as required.
- Present validation systems at internal and external audits
- Support quality assurance programmes
- Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements

Qualifications


Education and Experience:
- Relevant 3rd Level Qualification in science or engineering
- A minimum of 4 years IT validation experience in an established QA function preferably in the healthcare industry
- Strong knowledge of CSV/GAMP, 21CFR Part 11,Project Life Cycle and cGMP Regulations,
- Strong statistical skills and process capability are required along with excellent interpersonal, communication, facilitation and team working skills. Adaptable and flexible.
- Desirable:
- The person will have a proven track record in the qualification of any of the following
- systems :
- Qualification of Control Systems -Building Management Systems, Siemens PLCs,
- Qualification of IT and Business Systems including SAP, LIMS, QC Laboratory Systems, MES

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