Process Specialist

Brightwater

Cork

This is a great opportunity to join a world leader during a start up phase where you can develop that in depth knowledge that only a start up will afford you. Working on a Technical Transfer project you will be the first port of call for any technical issues associated with the manufacturing processes. You will work closely with the Process Lead to deal with all support issues, CAPA`s, deviations, investigations and so on. You`ll need a Level 8 qualification in Engineering or Science plus at least 5 years of experience in a Pharma or Biotech manufacturing environment. Responsibilities: Lead and participate in problem solving teams across all areas. Lead and close process related deviations and reports. Support Operations team to consistently deliver on specific area Key Performance Indicators. Protocol/report authoring/execution/oversight/approval as appropriate. Ensure supply of high quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives. Provide technical, process and engineering expertise within a wide range of projects, such as the introduction of new equipment and processes. Qualifications and Experience: Level 8 Degree or Masters in a Science or Engineering discipline (preferably Biotechnology. Preference for Lean Six Sigma qualification or experience of application of Lean principles. 5 years Engineering/Technical experience in biopharmaceutical/vaccines environment. Experience in a FDA / HPRA Regulated production environment. Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements. For more on the role call Nigel on 021 4221000 or send your CV for consideration . This job originally appeared on RecruitIreland.com.

2109 days ago