Validation Engineer

An innovative Medical Device company is experiencing major changes due to organic growth and now require a brand new facility in order to double their manufacturing output. They are currently seeking a Validation Engineer to support the project and support the validation team with GMP documentation, decommissioning and various hands on validation activities.

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
- Understanding the company's current manufacturing processes
- 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

- Degree in Science/Engineering or equivalent professional experience
- Validation experience within the medical device/pharmaceutical industry - essential
- Competent at process equipment 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 (eg Commissioning and Qualification)
- Understanding of the requirements of Lean manufacturing
- Experience of clean rooms; autoclaves; clean steam and pure water plant
- Self-starter and takes responsibility for completion
- Positive team-working and problem-solving skills
- Strong organisation and prioritisation

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.