Validation Manager Location: Cork, Limerick, Tipperary Salary: 75 000K - 85 000k


 

Validation Manager


This company is one of the largest medical device companies in the world with operations in Munster. Due to expansion, an exciting opportunity has arisen in their manufacturing facility in the Munster.

Role Highlights:

• Manage all of the validation engineering functions at the site.
• Lead, integrate & project manage validation tasks from initial concept through to successful completion and delivery.
• Continue to seek, support & drive cost saving initiatives where validation is involved or accountable for the functions.
• Develop the plans and resource requirements including skill mix to deliver the validation objectives whilst supporting development needs and operational efficiency.
• Co-ordinate validation activities with all stakeholders through commercialization.
• Implement validation processes and site master validation planning.
• Close co-ordinations with other functions such as engineering, quality assurance, safety, operations and production.
• Develop themselves as an expert in their area of responsibility for a long-term support of the operation.
• Prepare monthly reports with emphasis on timing and cost estimation in the area of responsibility.
• Follow cGMP guidelines, safety procedures, and SOPs at all times.
• Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.
• Be accountable that validation activity is conducted in compliance with US and EU legislation; as well as, the company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.
• Provide processes for validation activities in compliance with global regulations, GBSC procedures and EHS requirements.
• Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
• 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 plant priorities.
• Participate in cross-functional teams as required and Work in other areas as needed.

Essential Requirements:

• Educated to degree level in Engineering or Science related area.
• Minimum of 5 to 7 years’ experience gained within a medical devices/pharma manufacturing environment.
• Established track record in effective people/team management.
• Experience in project management and targeting effort through science based risk assessment.
• Excellent oral and written communication skills.
• High level of customer orientation/understanding.

For immediate consideration for this role please apply online or contact:

Shane Browne - (01) 632 1865
HRM Science Selection Team

YOUR CV WILL BE TREATED WITH THE STRICTEST CONFIDENCE

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