Job Description
Our client a leading provider of medical devices, supplies and pharmaceuticals now seek a Validation Quality Engineer. The Validation Quality Engineer will be 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.
This is an initial 18 month contract role in the Midlands.
Responsibilities of Validation Quality Engineer:
? 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.
? 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.
? Identify continuous improvements opportunities where possible and take part in improvement projects as assigned
? 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
Requirements of Validation Quality Engineer:
- Bachelor?s degree in a 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.
Please send an up to date CV and cover note to John Reid at the RFT Group / 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.