Job Title: CQV Engineer
Reporting to: Head of Managed Services
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. The successful candidate will support the Risked Based Verification transformation project to ensure all systems are in place and updates completed as required to transition to the new process.
· Utilise CQV expertise and support project management team to define and initiate new CQV process.
· Generate new procedures and templates;
· Update current procedures and template to align with Risked Based Verification;
Education and Experience Requirements:
- Bachelor’s degree in engineering, science or equivalent.
· Minimum 7 years’ experience in the Validation/CQV industry.
· 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.
· Excellent documentation skills.
· Project Management experience would be an advantage.
· A good understanding of current data integrity expectations would be an advantage.
· 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.
Why Join Crest Solutions?
In Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Crest Solutions benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:
· Competitive salary
· Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme
· A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment
· A structured approach to professional development opportunities with an educational assistance programme
Crest Solutions is an equal opportunity employer.