Job Title: Validation Engineer
A permanent, full-site position based in North Wicklow/South Dublin.
Key Responsibilities:
* Compilation and execution of validation protocols
* Compilation of validation summary reports
* Collection, testing, measurement, data entry, data analysis of samples
* Software validation
* Statistical analysis (particularly data interpretation, sample sizes)
* Validation documentation review
Requirements:
* Minimum 3 years industrial experience in a facility manufacturing pharmaceutical environment or equivalent products
* BSc. Level in a science or engineering related discipline or equivalent
* Knowledge of elements of validation documents (VMP / FAT / SAT / IQ / OQ / PQ etc.)
* Understanding of production operations, GMP and GLP requirements
* Demonstrated strong organisational skills from both administrative and hands on standpoints
Desirable Skills:
* Familiarity with incubators, fridges, freezers, cold rooms
* Filling, stoppering, capping, labelling, packing manufacturing lines
* Freeze Drying processing equipment
* Validation of Computerized Systems (FDA regulation)
* Microsoft office (Word, Excel, Power Point etc.)
* Statistical Software
Skills and Behaviours:
* Excellent communication skills (written and verbal), interpersonal and presentation skills
* Team focused, attention to detail, initiative, ingenuity, creativity, resourcefulness, flexibility and perseverance
* Ability to read, analyse, interpret technical data, interpret technical procedures, and governmental regulations
* Continuous Improvement mindset, demonstrated achievements from previous roles
Language Requirements:
Fluency in English, both written and oral, is a pre-requisite.