Validation Engineer

16 hours ago

Wicklow Town Co Wicklow, Ireland Tcoag Full time

Validation Engineer 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 Be an active contributor to Calibration activities on-site Qualifications/Experience required: Minimum 3 years industrial experience in a facility manufacturing in pharmaceutical environment, vitro diagnostic products or equivalent Educated to BSc. Level in a science or engineering related discipline or equivalent (preferrable) Knowledge of elements of validation documents (VMP / FAT / SAT / IQ / OQ / PQ etc.) (essential). Understanding of production operations, GMP and GLP requirements. Demonstrated strongorganisationalskills 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 whilemaximisingperformance Familiarity in the use of the following equipment, instrumentation and software would be advantageous: Incubators, Fridges, Freezers, Cold Rooms. Filling, Stoppering, Capping, Labelling, Packing manufacturing lines (fully automated, semi-automatic or manual) Freeze Drying processing equipment Validation of Computerized Systems (FDA regulation) Microsoft office (Word, Excel, PowerPoint etc.) Statistical Software Skills andBehaviours The successful applicant will have excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and be team focused. The successful applicants professional characteristics will include attention to detail, initiative, ingenuity, creativity, resourcefulness, flexibility and perseverance. The successful applicant will work with a sense of urgency, be able to prioritize appropriately, have excellent organizational skills and have the ability to be impartial and objective. The successful applicant will have a Continuous Improvement mindset, with demonstrated achievements from previous roles Have a willingness and ability to collaborate with and influence other groups, in a positive, team-based environment Have excellent problem solving and troubleshooting skills Ability to read, analyse, interpret technical data, interpret technical procedures, and governmental regulations. Be an active learner, developer of self, mentor coach and develop others Ability to prepare Power point presentations and/or effectively present information and respond to questions, within a group setting Identify with Tcoags philosophy of being Best in Class LanguageSkills: Fluency in English, both written and oral, is a pre-requisite. The above requirements is not exhaustive and is provided to show the most common tasks and may be amended or updated as required. Skills: Validation Process Validation Software Quality Management OQ Physical testing Benefits: Group Life Assurance Laptop Meal Allowance / Canteen Medical Aid / Health Care Paid Holidays Parking Pension Fund

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