Senior Packaging Engineer

Genentech•Hillsboro, OR

2d•$78,800 - $146,510•Onsite

About The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO produces millions of units of life-saving medicine every year for patients around the world. This position is located at Genentech's Hillsboro Technical Operations facility (HTO) in Hillsboro, Oregon. As a key member of the MSAT Process Engineering - Finished Goods team, this exciting role will focus on the design, sourcing, and qualification of secondary/tertiary packaging configurations and components to support new product launches and tech transfers at the HTO site. In this role you will also provide technical support for bulk packaged and finished goods shipping and distribution in the Roche network.

Requirements

B.S. degree in Packaging or a related engineering field
3-7 years of engineering experience in the pharmaceutical or other regulated field
Knowledge of design and qualification processes for secondary/tertiary pharmaceutical packaging configurations for small parcel and unitized distribution by truck and/or air
Experience with ASTM/ISTA/IATA standards and testing for packaging designs and medical devices
Familiarity with ArtiosCAD, Solidworks, and TOPS experience
Knowledge of pharmaceutical system qualification lifecycle is required
Knowledge of change control systems in a cGMP environment
Detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions
Strong communication and interpersonal skills, with the ability to collaborate effectively in a cross-functional team environment
Ability to work with little direction to organize and accomplish tasks
Demonstrated skills in the application of project management tools

Nice To Haves

Knowledge of secondary and tertiary packaging and related equipment and processes is beneficial

Responsibilities

Implement new packaging configurations at the HTO site for new product launches and tech transfers
Qualify new packaging configurations both mechanically and thermally (as needed)
Closely collaborate with site and network organizations seamlessly
Support risk analysis activities as required for secondary / tertiary packaging and shipping qualifications
Create/maintain packaging item specifications in cGMP environment
Provide technical expertise concerning secondary and tertiary packaging materials
Provide technical support during all phases of the qualification and validation of packaging equipment
Support the Finished Goods and Fill Finish Value Streams to resolve packaging material quality issues
Support the creation and maintenance of packaging artwork
Support investigations and root cause evaluations that are secondary or tertiary packaging related
Partner with Procurement to select and qualify packaging material vendors
Work directly with packaging material vendors to provide innovative and cost effective solutions