Amgen Process Development Sr Engineer - Packaging SME in Dublin, Ireland
This role will require the candidate to lead packaging activities for transfer of vial and syringe combination products and the on-going support to Manufacturing. The candidate will provide technical support to the Packaging areas at Amgen Dun Laoghaire (ADL) as well as being part of the global Process Development organization. The input provided will include support of process performance and implementation of process improvement strategies and will include the following:
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.
Troubleshoots issues with packaging equipment and associated vision systems.
Conducts risk assessment for packaging operations and propose / implement appropriate 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.
Development of 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.
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.
Participate as required in project activities.
Contribute to Product Quality Assessments and process flow documents.
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
Experience working with teams and influencing decisions
Excellent written and verbal communication skills together with demonstrated ability to work in a team environment
Proven track record of problem solving as well as leading and executing cross-functional projects
A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience
Preferred Qualifications .
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.
Strong skills in applying fundamental engineering and scientific principles to the design and implementation of combination product/final pack processes
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.
Excellent written and verbal communication skills are essential for this role.
Knowledge of applicable Regulatory requirements
Experience with Regulatory inspections desirable