This position is located at our client' s primary United States biologics packaging and distribution facility, Hillsboro Technical Operations (HTO) in Hillsboro, Oregon. The position is located within the Inspection and Packaging MSAT Team which is responsible for the design, sourcing, qualification, and maintenance/trouble shooting of secondary/tertiary packaging materials and components. This position will provide design support for bulk packaged and finished goods shipping and distribution. Role:
The Senior Packaging Development Engineer will lead/participate in teams to qualify new packaging configurations to support product launches at the HTO facility. Scope includes authoring all required design, qualification plan, engineering protocol, and summary report documentation and coordinating the execution of all associated qualification activities in a cGMP environment. The Senior Packaging Engineer ensures regulatory compliance by completing the qualification of packaging configurations within the required launch timeline. The Senior Packaging Development Engineer will facilitate risk analysis activities as required for all secondary / tertiary packaging items and shipping qualifications.
The role includes creating/maintaining packaging component specifications, review/approval of packaging artwork, and the introduction of packaging Bill of Materials in a cGMP environment. The Senior Packaging Development Engineer will partner with Procurement to select and qualify packaging material vendors as needed. Skills:
- B.S. degree in packaging engineering or other engineering field
- Possess 5 - 8 years of experience designing and qualifying secondary/tertiary packaging configurations in a pharmaceutical manufacturing environment
- Experience with ArtiosCAD and TOPS is preferred
- Experience with change control processes in a cGMP environment is preferred
- A basic understanding of SAP is required, with working knowledge of SAP preferred.
- Knowledge of secondary and tertiary packaging equipment and processes is preferred
- Professional level written and oral communication skills
- Demonstrated skills in working with minimal direction to organize and accomplish tasks
- Demonstrated skills in the application of project management tools
- Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries
Associated topics: baked good shipper, finished goods packager, packaging back up coordinator, packaging coordinator, packaging engineer, packaging equipment, packaging position, packaging scientist, packaging technician iv, senior packager