Equipment & Process Validation Engineer with excellent understanding of EN ISO 13485:2016, MDSAP & FDA requirements required for Galway role. Due to continued expansion into global markets, my client – a growing Irish medical devices company – is seeking to recruit an Equipment & Process Validation Engineer to lead the validation strategy & deliver on strategic projects including material change, new equipment, and continuous improvement projects. This role should aspire to become the site subject matter expert on validation and champion the improvement of current systems, procedures, practices with a view to optimizing validation execution.
- Level 7 qualification in Engineering, Technology or Science along with a Trade Certificate and minimum 8 years experience OR Level 8 qualification in Engineering, Technology or Science with minimum 4 years experience
- Knowledge of Process Validation and use of risk tools to generate sampling plans essential for this role.
- Excellent understanding of EN ISO 13485:2016, MDSAP and FDA requirements
- Excellent equipment and Process validation knowledge
- Working knowledge of TMV and Computer Systems
- Excellent knowledge/experience of Risk Based Techniques i.e. pFMEAs, dFMEAs
- Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, TMV’s
- Self-starter with ability to work independently under pressure and react quickly to changing priorities
- Meticulous attention to detail while also conveying a sense of urgency
- Must have the ability to communicate effectively and concisely at all levels of the company
- Proficiency in Microsoft Office software.
- Driver’s license & car as there is travel between two sites in Galway and Clare
- As a team member of Engineering projects lead the validation strategy support qualification of process change, new product, new material and new equipment.
- Generation/maintenance/execution of the Site Validation Master Plan & of Project Master Validation Plans
- Generation of validation protocols to include URS, FAT, SAT, IQ, CSV, OQ, PQ and PPQ
- Perform data analysis in support of validation report generation and make informed decisions/recommendations around conclusions reached
- Generation of validation investigations and implementation of corrective actions
- Performing cross training within the team and training of new team members
- Presenting validations at both internal and FDA, NSAI and customer audits
- Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or execute validations
- Establish Validation standards in terms of Industry Best Practices and drive this level across the organization
- Responsibility to generate and implement improvements to streamline validation execution.