Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.
Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification. and validation as required.
• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting.
• Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
• Considerable experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business; in a GMP manufacturing setting.
• Demonstrated technical leadership and delivery of complex cross functional / cross site projects. SME in multiple aspects of aseptic processing.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job related computer applications required.
• Lean Six Sigma Methodology experience desired.
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