Senior Process Development Engineer
- The Senior Process Development Engineer will lead 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.
- A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience is essential
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Direct experience with medical devices/combination products and associated manufacturing processes and vision systems
- Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
- 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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