Our client, a medical device company in Mayo is currently looking to recruit a CQV Engineer for their site.
- The CQV Implementation Engineer shall be responsible for transitioning the CQV approach from the current V-model approach to a Risked Based Verification (RBV) approach based on ASTM-E2500.
- The primary responsibility of the role is to help create the new process, generate a project plan for implementation, generate the required documents and update procedures and work instructions as required by the change.
Utilise CQV expertise and support project management team to define and initiate new CQV process.
- Align site process with corporate Policies and SOP’s
- Define Engineering approach to critical systems projects
- Define validation approach
- Work with Risked Based Verification (RBV) transformation team to deliver transition from V-Model validation to RBV
- Liase with QA to develop Vendor audit Requirements
Generate new procedures and templates;
- URS Procedure and Templates
- Engineering Change Control
- System Level Impact Assessment
- CQV Site Procedure
- Training Plan
Update current procedures and template to align with Risked Based Verification;
- Engineering Procedures and Technical Templates
- Project Management Procedures
- Project Templates
Education and Experience
- Bachelor’s degree in engineering or equivalent.
- Minimum 7 years’ experience in the Validation/CQV industry.
- A proven track record that demonstrates the ability to work without direct supervision whilst maintaining adherence to project delivery is fundamental to the role.
- Good interpersonal and communication skills essential for working across multi-functional teams.
- Comfortable to take on large / complex projects containing multiple modules and multiple Vendors with interlinked systems.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Comprehensive understanding of Validation principles and practices.
- Comprehensive understanding of Risked Based Verification and ASTM-E2500-13 and relevant EU/FDA regulations.
- Understanding of Process Validation, Computer system Validation, SCADA systems, CPV, Sterilization, Packaging systems and related technologies.
- A good understanding of current data integrity expectations would be an advantage.
- Ability to respond to emergency changes that may present themselves while maintaining high levels of GxP throughout the validation effort.
- Project Management experience would be an advantage
For further information on this CQV Engineer role in Mayo please contact Karl Lippett on 086 1070950 / firstname.lastname@example.org
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