Engineer, Primary​/Secondary Packaging -Regulatory Compliance, Design and Qualification JP

Engineer, Primary/Secondary Packaging
-Regulatory Compliance, Design and Qualification

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

This position reports into the Clinical and Platform Packaging Engineering group under Combination Products Operations in Thousand Oaks, CA. This position will apply engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and material science is essential to the position.

The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environments.

Backfill.

Top Must Have

Skills:

• Regulatory Compliance experience, Design and qualification experience, and Cross-functional collaboration

Day to Day Responsibilities:

• Support for testing and evaluation leading to recommendation and selection of primary and secondary packaging materials.
• Familiarity with Material Testing standards, requirements and equipment is essential.
• Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components.
• Writing technical specifications, creating engineering drawings, and developing artwork templates.
• Competent with AutoCAD, Illustrator, or similar software application to create, modify and approve engineering drawings.
• Support line trials and packaging validation activities prior to introduction of any new or change in components/processes.
• Collaborate with cross-functional teams (i.e. Quality, Device Engineering, Supply Chain, Artwork, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:

No technical experience. We are not looking for project managers.

Interview process:

MS Teams interview with manager, then likely interview with 2 other senior managers and 1 Sr. Engineer