Packaging Engineer - medical/ pharma
Elstree, Herts
to start ASAP
Excellent salary and benefits,

Our client is a leading medical technology company offering innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes is seeking an experienced Packaging Engineer to support the Product Support Engineering Packaging process for cleaning and packaging of Sterile Medical Device implants.

Key areas of responsibility
* Provide Packaging Subject Matter Expertise for Sterile Packaging of Medical Device Implants.
* Perform remediation of existing sterile packaging and cleaning for Medical Device implants to comply with ISO11607-1 and ISO11607-2 (Packaging For Terminally Sterilized Medical Devices).
* Work closely with all cross functions in the business, especially core project teams, marketing, regulatory, quality and operations to support the business objectives.
* Lead the post launch assess phase activities of all product packaging design solutions for products.
* Provide technical support to both the Quality Assurance and Regulatory teams to help investigate and recommend solutions to any package design related issues and the completion of technical assessments/SofHA's where applicable.
* Own all package design related NCR/CAPA's for the Packaging Group and ensure timely closure of all issues in line with procedure guidelines.
* Conduct VOC (voice of the customer) for packaging and transfer it into appropriate action with regards to packaging design ensuring proactive and satisfactory closure with the customer
* Provide technical support to Packaging Operations to help troubleshoot, investigate, and recommend solutions to any package related issues.
* Provide technical support to the Supply Chain team on any package related supplier issues or re-sourcing activities.
* Determine, coordinate and execute physical package testing to ensure product and package integrity.
* Write and perform test protocols for evaluations and validation.
* Interface with the Global PSE Packaging Group and other Advanced Operations team members both locally and globally, Quality Assurance / Regulatory and Operations Teams to ensure equivalency of approach in Equipment, Processes and Validation techniques.
* Maintain an overview of state-of-the-art technologies within medical device packaging through understanding of technology, clinical practice, regulatory environment and competitive and intellectual property landscape assessment.

Experience and Qualifications required:
* Bachelor of Science Degree in Packaging, Engineering or Science is required.
* The individual must have a minimum of 5-10 years relevant packaging experience within a regulated environment - FDA, ISO etc.
* Business understanding of operations and their individual impact is essential.
* Strong communication skills with both Internal and external agents.
* Flexibility essential with strong project management skills.
* The individual should enjoy working in a dynamic and results motivated team based.
* Strong cross-functional leadership skills and ability to influence matrixed teams.
* Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
* PC literate and strong knowledge of Microsoft Office tools are essential.

Experience and Qualifications desirable:
* Thorough knowledge of primary and secondary component materials, systems, and converting processes.
* Broad understanding of Design Control process and experience developing products under these guidelines.

For a confidential discussion please call Rosie Carden 01707 247 259

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

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