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Validation Engineer

  • Job reference: 935153
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 28/04/2021

Validation Engineer

The Orion Group are recruiting for a Validation Engineer for our Medical Device Client, Experience with IQ/OQ/PQ, Validation Plans, FDA regulatory validation and Electronics experience a distinct benefit.

Key Responsibilities & Duties

o Support, Maintain and improve the site validation program and ensure compliance to the quality requirements as set in the ISO 13485 and MDR

o Experienced with FDA quality & regulations

o Strong skills to bring teams along with their understanding of validation activities, including Test Method validation and overall process validation.

o Writing and reviewing protocols, reports deviations, supporting change control, and release to production after validation activities.

o Ensuring process and equipment validations meet current regulatory expectations by providing guidance and executing both internal and external audits of our processes

o Approval of site process and equipment validation documentation such as protocols, deviations and final reports.

o Providing support for change controls in relation to validation

o Managing and coordinating validation support during the execution of the project

o Serving as the validation liaison with all vested parties including QA/QC, IT, Manufacturing, R&D, and Engineering

o To provide reports to management on validation related issues, compiling metrics to demonstrate the effectiveness of the Quality Management System, support management review.

o Co-ordination and assistance to the NCR and CAPA systems relating to validation.

o Promote quality and compliance

o Taking part in cross-functional risk assessments

o Support product development where required.

o Support Root Cause Analysis.

o Continuous Improvement

o Identification of systems or work practices which can be improved and recommendation of alternative approaches towards improvement.

o Qualifications & Experience

o At least 5 years' work experience as a Validation Engineer within Quality in medical device industry

o Degree in a Quality, Science or Engineering discipline

o Aptitude and Ability

o Detail focused

o Flexibility and adaptability

o Problem solving

o Knowledge and Skills

o Excellent verbal and written communication skills

o Excellent computer literacy - Excel and Word

o Promote understanding of regulations and standards and their practical implementation

o Strong organizational skills


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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