Job Description
**Senior Packaging Engineer**
A highly visible role responsible for leading the planning and execution of packaging projects for a wide variety of project types, including new product introductions, tech transfers, and quality workstreams.
**Job Description**
At Gilead, we're creating a healthier world for all people. We're looking for a Senior Packaging Engineer to join our Global Manufacturing, Packaging & Labelling Business Operations organisation.
**Key Responsibilities:**
* Lead the planning and execution of packaging projects for a wide variety of project types, including new product introductions, tech transfers, and quality workstreams.
* Support and/or lead external packaging operations for Contract packaging site(s) in the EMEA region.
* Develop and implement packaging solutions for a range of Gilead products across the Gilead Manufacturing network.
* Design and conduct package testing and transportation studies for a range of pack formats.
* Provide ongoing technical and operational support to Contract Manufacturing Partners (CMOs) globally.
* Contribute to the development of the packaging capabilities.
**Job Duties:**
* Packaging Engineering & Operations:
+ Support and/or lead the planning and execution of packaging projects.
+ Support and/or lead external packaging operations for Contract packaging site(s) in the EMEA region.
+ Develop and implement packaging solutions for a range of Gilead products.
+ Design and conduct package testing and transportation studies.
* Device and Kit Assembly:
+ Support and/or lead the engineering, operational and testing of secondary packaging presentations for combination devices/kits.
+ Develop innovative, creative, and cost-competitive secondary packaging/kitting solutions.
+ Understand major regulatory requirements and support review of regulatory submission documents.
* Project Management:
+ Support packaging projects and follow global guidelines on project delivery.
+ Use change control systems and project governance policies & systems.
* Cost Efficiency and Continuous Improvement:
+ Lead and oversee approved cost savings projects across the sites and CMOs.
+ Analyze packaging engineering processes and documentation practices to identify and implement continuous improvement initiatives.
**Requirements:**
* Degree in Packaging/Device/Quality Engineering or related field.
* Extensive experience within the pharmaceutical, biotech or related industry.
* Strong technical and scientific skills with proven experience in the development of packaging solutions for OSD, parenteral and/or device packaging.
* Demonstrates strong knowledge of cGMP & regulatory processes.
* Experience of primary and secondary packaging processes, device and kitting assembly process, transportation studies, qualification/validation.
* Project Management and Stakeholder management experience.
* Strong communication, teamwork and organisational skills.
**Behaviours:**
* Ability to engage and partner with multiple stakeholders to achieve the objective.
* Curious with learning agility.
* Operationally excellent.
* Organised with systematic approach to prioritisation.
* Process orientated to achieve the business objective.