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Senior Process Development Engineer

Job description

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

  • Approve process 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

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