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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.
  • Acts as a combination product technical expert to provide solutions when troubleshooting Final Product Technologies (FPT) issues through the NPI or post-NPI phases.
  • Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
  • The Process Development Engineer will 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.
  • Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
  • This job will involve developing characterisation Plans, IOQs and PQs
  • Ensuring all aspects of activity within any given Design Transfer adheres to required policies and procedures, including safety and training.
  • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
  • Participate in Qualification Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
  • Pre-approve and post-approve process characterisation/qualification/validation protocols and assessments from a quality system documentation perspective.
  • The Process Engineer will 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;

  • A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience 
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Direct experience with medical devices/combination products and associated manufacturing processes and vision systems
  • Experience of working with equipment suppliers
  • Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
  • 5 + years of experience in support of Commercial Finished Drug Product (FDP) processing in specific areas such as Process Characterization, Tech Transfer 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.
  • Knowledge of applicable Regulatory requirements
  • Experience with Regulatory inspections desirable

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