Senior Packaging Engineer - SME - Amgen


Location: Ireland

EUR 45 - 55 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1901-12447

Consultant: Karen McHugh






Are you a Packaging Engineer with experience leading a cross functional team? 

Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development?

If you have the relevant experience, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.


Senior Packaging Engineer - SME - Amgen


Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.


Job Description

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: 

Key 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. 

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. 


Requirements

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


Package

€45 - €55 per hour

Minimum Contract duration: 12 months


Contact

Karen McHugh is the consultant managing this position. 

If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720

TAGLife


Apply For Senior Packaging Engineer - SME - Amgen


Upload CV
.doc, .pdf, .txt, .rtf, .html Files Accepted
Karen at Jobcontax