Description
An innovative Medical Device company is undergoing construction for a brand new building to house their Global Headquarters and main manufacturing facility. They are currently seeking a CSV Engineer to support the project and support the validation team with an ERP update.Our client is experiencing major changes due to organic growth and now require a brand new facility in order to double their manufacturing output.
- The successful candidate will be responsible for, but not limited to the following:
- Preparing and completing validation documentation / protocols, using site SOPs and templates
- Performing Installation Qualification (IQ), Operational Qualification (OQ) and running Performance Qualification (PQ) activities
- Completing computer system validation (CSV) activities
- Preparing and completing validation documentation / protocols and executing to the required quality and timelines.
- Maintaining a professional relationship with multiple internal customers.
- Execution of protocols to the required quality and agreed timelines.
- Producing documentation in line with our change control processes and managing deviations (with suppliers and internal customers) to closure in a compliant and traceable manner.
Requirements:
- Educated to a Degree level, preferably in Science/ Engineering or hold equivalent professional experience.
- Validation experience within the Medical Device/Healthcare/ Pharmaceutical industry
- Fully competent at CSV specification and validation with a full understanding of special purpose machines
- Solid working knowledge of cGMP, 21 CFR Part 820, Quality Systems Regulation and European Medical Device Directives and international standards such as ISO 13845 Medical Device Standard
- Working knowledge of industry practice such as ISPE GAMP, ISPE Baseline Guides (e.g. Commissioning and Qualification)
We are looking for a self-starter who takes responsibility for completion and has strong organisation and prioritisation skills.
If you hold the relevant experience and would like to be considered for this incredible opportunity, please apply today with an email highlighting your key skills and relevant experience aligned to this opportunity.