Job Description
PE Global is currently recruiting for a Process Scientist for a leading multi-national Pharma client based in Dublin. This is a 12 month contract position. Role: Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping. Key contributor to product and process investigations, responsible for assessing product and process impact. Leads continuous improvement projects to improve process performance and productivity. Assess product impact associated with proposed changes to commercial processes under the change control process. Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation. Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support. Review and approve changes to operating procedures, electronic batch records, and product documentation. Identifies and implements operational opportunities for current and new sterile operations. Risk assessments and mitigation projects relating to line performance. Perform process gap analysis and developing strategies to close gaps. Data trend analysis for all performance aspects of the area. Troubleshooting performance trends. Requirements: Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation Qualification in Lean and 6-sigma methodologies would be an advantage. New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous. Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: NPI Process Development MSAT lyophilisation