Validation Engineer
We are currently recruiting for a Validation Engineer on behalf of our client, a global medical devices company. This is a permanent, full-site position based in North Wicklow/South Dublin.
Reports To:
Maintenance, Engineering and Validation Manager
Essential Responsibilities:
* Compilation and execution of validation protocols
* Compilation of validation summary reports
* Collection, testing, measurement, data entry, and data analysis of samples
* Software validation
* Statistical analysis (particularly data interpretation and sample sizes)
* Validation documentation review
* Active contributor to calibration activities on-site
Qualifications/Experience Required:
* Minimum 3 years of industrial experience in a facility manufacturing pharmaceutical products or equivalent
* Education to BSc level in a science or engineering-related discipline or equivalent (preferable)
* Knowledge of elements of validation documents (VMP / FAT / SAT / IQ / OQ / PQ etc.) (essential)
* Understanding of production operations, GMP and GLP requirements
* Demonstrated strong organisational skills from both administrative and hands-on standpoints
* High level of care and attention to all aspects of the role and desire to achieve excellence through own initiative
* Proven team player, capable of working within multiple areas while maximising performance
Familiarity with Equipment, Instrumentation, and Software:
* Incubators, Fridges, Freezers, Cold Rooms
* Filling, Stoppering, Capping, Labelling, Packing manufacturing lines (fully automated, semi-automatic or manual)
* Freeze Drying processing equipment
* Validation of Computerised Systems (FDA regulation)
* Microsoft Office (Word, Excel, PowerPoint etc.)
* Statistical Software
Skills and Behaviours:
* Excellent communication skills (both written and verbal), excellent interpersonal and presentation skills, and team-focused
* Professional characteristics including attention to detail, initiative, ingenuity, creativity, resourcefulness, flexibility, and perseverance
* Work with a sense of urgency, prioritise appropriately, have excellent organisational skills, and ability to be impartial and objective
* Continuous Improvement mindset with demonstrated achievements from previous roles
* Ability to collaborate with and influence other groups in a positive, team-based environment
* Excellent problem-solving and troubleshooting skills
* Ability to read, analyse, interpret technical data, interpret technical procedures, and governmental regulations
* Active learner, developer of self, mentor coach, and develop others
* Ability to prepare PowerPoint presentations and/or effectively present information and respond to questions within a group setting
Language Skills:
Fluency in English, both written and oral, is a pre-requisite.