Device Packaging Engineer

Sandoz•Cambridge, OH

About The Position

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! The Device Packaging Engineer will be Key Member of the Sandoz Device Development Centre Team with overall responsibility for medical device and combination product packaging specification, design development and testing activities. They will represent specialist packaging area (SME) on Device Project Teams and delivers on key packaging project tasks within complex generics and biosimilar development workstreams.

Requirements

Proven track record (3 to 5 years) in development of packaging for medical devices and /or combination products within a pharmaceutical, medical devices, and/or combination products setting.
Ideally higher level qualification (additional experience will be considered in lieu of formal qualification) in Science/Engineering or Product Design discipline
Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USA, Europe)
Significant career examples working in matrix teams
Track record of goal-driven behaviour, problem-solving, ability to make pragmatic decisions, readiness for new challenges
Given examples of working in complex projects involving MedTech products where candidate played a significant role
Experience of interfacing with MedTech CMO's and suppliers whilst representing a professional organisation.
Ability to lead and control interactions to achieve desired outcomes

Responsibilities

Knowledge of secondary and tertiary packaging materials, designs and typical applications in pharmaceutical packaging in particular with relation to medical device and combination products
Experience of inputting into and writing packaging related sections of Design History File documentation (e.g PRD, DIR, Intended Use etc.)
Demonstrate understanding of best practices and regulatory requirements surrounding verification/validation of secondary packaging
Experience of producing technical drawings for in-house design concepts of folding boxes, direct pack folding inlays, and blister trays etc.
Experience of liaising with secondary packaging vendors and CMO’s to develop designs and manufacture solutions
Provide expertise and input into device packaging manufacturing activities including DFM, Risk Assessments and equipment suitability/ compatibility.
Interface with stakeholder groups from RA labelling, artworks and manufacturing (internal and CMO) on project packaging deliverables
Shipping & transport packaging development & verification testing for medical/pharma products
Input into Quality events during development related to packaging e.g. Change controls, CAPAs etc.
Contribute to the training and development of colleagues by acting as coach/mentor on packaging matters as appropriate