Validation Engineer Role
Reports to Maintenance, Engineering and Validation Manager
Essential Responsibilities:
* Compilation and execution of validation protocols
* Compilation of validation summary reports
* Collection, test, measurement, data entry, data analysis of samples
* Software Validation Statistical Analysis (in particular data interpretation, sample sizes)
* Validation documentation review
* Active contributor to Calibration activities on-site
Qualifications/Experience Required:
* Minimum 3 years industrial experience in a facility manufacturing pharmaceutical environment, vitro diagnostic products or equivalent
* Educated 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
* Demonstrate a high level of care and attention to all aspects of the role and show a desire to achieve excellence through own initiative
* Proven to be a team player, capable of working within multiple areas while maximising performance
Skills and Behaviours:
* Excellent communication skills, (both written and verbal)
* Excellent interpersonal and presentation skills
* Team-focused
* Attention to detail
* Initiative
* Ingenue
* Creativity
* Resourcefulness
* Flexibility
* Perseverance
* Continuous Improvement mindset
* Ability to read, analyse, interpret technical data
* Interpret technical procedures, and governmental regulations
* Fluency in English, both written and oral, is a pre-requisite