Validation Engineers

We are currently recruiting for Validation Engineers to work in this large manufacturing company.
The main purpose of the validation engineer’s role is to support validation activities associated with the delivery of product transfer project work. The positions are intended to be for a fixed 2 year period (with flexibility of being extended). The roles will be part of a team supporting site transfer projects from one facility to another.
The key tasks of the Validation Engineer’s roles include:
• Working with cross functional teams to develop project plans and ensure adherence to schedules and project deadlines
• Development of process validation protocols
• Assisting with the execution and documenting the process validations and verification in supporting the MVP
• Development of SOP, Quality Plans and Inspection Criteria
• Interpretation of Engineering drawings and product specifications
• Maintenance of the MVP
• Support of Company audit procedures and identifying risks to the business
• High standard of technical report writing
• The ability to read, analyse and interpret scientific and technical reports and respond to enquiries from regulatory agencies.
The following skills/experience are required for the Validation Engineers roles:
• Degree in an engineering discipline or equivalent (ideal)
• Demonstrate a thorough understanding of QA practices and procedures within a regulated industry
• Knowledge of FDA requirements for Process Validation, and the contents of both 21 CFR 820 and ISO 13485
• Experience in metrology techniques with a proven track record in design for manufacturing analysis and definition of control strategies for in process inspection.
• Strong software validation experience and the ability to project manage using industry recognised tools in required, in order to maintain control and be recognised as the reference point for multiple discrete and continuous projects.
• Ability to comprehend, and apply the principles of statistical process control, sampling plans, factor analysis and correlation techniques.
• Domestic and international travel may be required.
In return, my clients are offering a salary of between £35- 40k pa plus company benefits.
To be considered for the Validation Engineer’s roles, we are looking for applications from candidates with the above experience from within either a medical devise, pharmaceutical or a highly regulated industry.
This is initially a two year fixed contract role with a retention bonus to be paid on project completion.
To be considered for this role, please send your CV and covering letter today.