Software Quality Engineer-1417579W
Description
Position Title: Software Quality Engineer
Department: Quality
Report to: Quality Manager
Location: Limerick
Global Compensation Framework Band Number: 25
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
Key Skills and Competencies required:
• 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
o 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)
Job Function: Quality (Eng)
Description
Position Title: Software Quality Engineer
Department: Quality
Report to: Quality Manager
Location: Limerick
Global Compensation Framework Band Number: 25
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
Key Skills and Competencies required:
• 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
o 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)
Job Function: Quality (Eng)