Senior Process Development Engineer
Senior Process Development Engineer. Job Responsibilities: Leads Packaging NPI activities from a Process Development perspective and serves as the Process Development Packaging SME. Troubleshoots issues with packaging equipment and associated vision systems. Conducts risk assessment for packaging operations and propose / implement CAPA. Identifies and implements operational opportunities for current and new packaging operations. Development of Characterisation Plans, IOQs and PQs. Ensuring all aspects of activity within any given Design Transfer adheres to required policies and procedures. Approveprocess characterisation/qualification/validation protocols and assessments from a quality system documentation perspective. Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process. Assist in deviation and exception resolution and root cause analysis. Contribute to Product Quality Assessments and process flow documents. Job Requirements: Knowledge of cGMPs and other worldwide regulatory requirements. Direct experience with manufacturing processes and vision systems. A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role. 5 + years of experience in support of Commercial Finished Drug Product (FDP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial FDP sites) or Validation. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Packaging and Validation. Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. If you would like to find out more call Clara on 01 4744676. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website. This job originally appeared on RecruitIreland.com.
168 days ago