Senior Process Development Engineer
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.
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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