Our client, a medical device company in Westmeath are currently looking to recruit a Senior Validation Engineer for their site on a 12 month contract.
Responsible for supporting the validation activities within the plant. In addition, required to provide quality engineering leadership on multiple cross functional project teams. The role will be responsible for providing input and critical review and approval of all validation activities at the plant. This will include, but not be limited to Process Validation, Steriliser Validation, Software Validation, Equipment Validation, Utilities Validation, and Facilities Validation activities. Responsibilities include reviewing and approving protocols and test reports for processing equipment, laboratory equipment, facility systems, control systems, process validation for the manufacture of medical devices. Other responsibilities include performing quality and risk management.
- Use quality engineering techniques to ensure products released for distribution meet their intended performance requirements for safety and efficacy.
- Data collection, data interpretation and analysis, root cause analysis and report writing.
- Assist in the design, analysis and approval of IQ, OQ, PQ, and PV protocols and reports.
- Communicate and teach validation approach and requirements.
- Maintain master validation plans.
- Assess proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.
- Participate and provide assistance and technical support on technical project teams as a subject matter expert on process validation regulations/procedures.
- Support technology transfer of processes.
- Critically review and provide support for validation sections of regulatory submissions where required
- Work closely with Regulatory, Operations and R&D Departments.
- Quality and risk management as it pertains to the validation process.
- Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
- Work on significant problems of diverse scope in which analysis of situations or data requires an in-depth evaluation of variables.
- Provide quality engineering support in supplier quality assessments and issues.
- Identify continuous improvements opportunities where possible and take part in improvement projects as assigned
- Maintain a place of work that is safe and without risk to health
- Ensure compliance with relevant Company and Corporate requirements and legislation governing health and safety as principally contained in the 'Safety, Health and Welfare at Work Act 2005 and the Safety, Health and Welfare at Work (General Application) Regulations 2007.
- Ensure that all accidents and incidents are fully investigated and corrective action is taken to prevent recurrence.
- Implement Environmental programmes and procedures and obtain and abide by any environmental legal permits and licences necessary for the business activity.
- Strive to minimise the use of materials and chemicals, and waste generated from our activities in order to minimize environmental impact.
- Quality Engineer
- Calibration Engineer
Education & Experience
- B.S. or M.S. in Engineering, (Preferably Chemical or Mechanical) or equivalent discipline
- 8 + years of Quality, Process Development, Process Validation, or Manufacturing engineering experience in the medical device and/or pharmaceutical industry.
- Project Management Experience
- ASQC/ Green Belt/Black Belt certification preferred, not required.
For further information on this Senior Validation Engineer role in Westmeath please contact Nicola O'Connell on 091730022 / firstname.lastname@example.org
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