Hobson Prior are currently recruiting for a CSV Engineer for an exciting opportunity to join a manufacturing organisation who specialise in diabetic products. Their aim is to improve the quality of life for people who suffer from diabetes and this role will be on a contract basis. In this role you will provide daily support, supervision and prioritization of a team of engineers with expertise in Computer Systems and Computer Systems Validation.
- Provide a high level of technical knowledge and practical experience of Computer Systems and Computer Software Validation. (Including automated manufacturing systems, automated quality systems and tools, computer applications for business, bespoke computer software specification, design and systems testing).
- Guide the CSV team, directing daily tasks and planning for future deployment.
- Represent as CSV department Subject Matter Expert and present CSV validation documentation during internal and external inspections.
- Train others in the CSV function, provide coaching, feedback and direction to project teams.
- Interprets a given strategy into tactics and measures independently.
- Significant involvement in cross functional and global projects.
- Leads complex validation projects and projects within own function.
- Guide Project Managers, Project Owners & Project Teams regarding specific CSV requirements & responsibilities.
- Resolve & manage technical operational problems, provide solutions to difficult technical issues and influence technical and process improvements.
- Makes decisions based on data. Understands the balance of day-to-day activities versus big picture. Can assess risk and act appropriately.
- Assess and approve CSV validation and quality system documentation.
- Make sure validation activities and documents are authorised and appropriate compliance approval is gained.
- Deliver periodic validation review support to current regulatory and company standards through the QMS.
- Teach the company values in all actions within the workplace and promote the value of diverse perspectives.
- Implementing initiatives that will deliver customer value at lowest cost.
- Build relationships externally and internally for the CSV function and influence business partners & suppliers to ensure product quality and compliance to quality systems.
- Minimum of 3 years working from regulated environments.
- SME knowledge of computer systems & software design, development and validation.
- Working knowledge of design control.
- Product lifecycle and manufacturing knowledge.
- Risk management tools (FMEA, SRA, DOE).
- Software configuration management and change control.
- Experience with computer systems and software development validation and/or testing activities.
- Understanding of FDA & European Regulations relating to the Medical Devices Industry and best practices guidelines i.e. 21 CFR Part 11, 820 & ISO 13485 and GAMP.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.