Packaging Engineer II

Job Type: Full time
Job Nature: 100% Remote
Location: San Francisco, CA
Posted: Sep 21, 2021
Level: Other
Category: Other

THE POSITION

*Total of 3 Openings for Packaging Engineer II*

 

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

 

"Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.

 

“U.S. BIOLOGICS TECHNICAL DEVELOPMENT” (PTDU) DEVELOPS AND SUPPORTS MANUFACTURING PROCESSES, FORMULATIONS, DELIVERY DEVICES, ANALYTICAL METHODS, PACKAGING SOLUTIONS AND MATERIALS TO MEET END-TO-END (DISCOVERY TO COMMERCIALIZATION) DEVELOPMENT NEEDS OF THE GRED PROTEIN PHARMACEUTICAL PIPELINE THROUGH INNOVATION, EFFICIENCY, AND COLLABORATION TO ENABLE THE DELIVERY OF NOVEL MEDICINES THAT CAN MEET THE CRITICAL NEEDS OF PATIENTS.

In the Device and Packaging Development Department, we are responsible for the development of medical devices, combination products and packaging systems for R&D portfolio drug products. Our activities comprise a wide range of engineering disciplines ranging from the initial definition of product requirements to first commercialization and subsequent product care considering required regulatory, legislative, ecological, economical and technical aspects.

As a packaging engineer, you support the establishment of a world-class packaging organization by providing technical expertise in the development, qualification and deployment of new packaging systems. You will work on a variety of packaging initiatives and lead the development and qualification of global packaging solutions of assigned projects for clinical and commercial use. You will play a vital role in designing the best packaging for new molecules coming through the pipeline and launches. This activity involves close cooperation and cross-functional interaction with Technical Development Teams, Regulatory, Operations, CMO’s, Quality, Suppliers and other involved stakeholders.

 

Job Responsibilities

  • Lead packaging engineering projects within global teams in order to meet predefined timelines, quality, and budget
  • Deliver innovative, best in class packaging solutions to meet patient and business needs.
  • Develop and qualify global primary and secondary packaging solutions for products through the packaging lifecycle, understanding customer needs and leveraging the organization.
  • Innovate: Evaluate and screen new technologies, and new materials and/or packaging solutions based on patient, product, regulatory, business or technical requirements.
  • Ensure compliance with international procedures and external regulations.
  • Actively support a culture of knowledge sharing and interaction across packaging and device development teams.
  • For senior level positions, an additional key responsibility is to provide technical mentorship to team members in the department.

 

Education & Qualifications:

  • This position requires a Bachelor degree in materials science, mechanical, chemical, packaging engineering or similar; with a minimum of 5+ yrs w/ Bachelors working in packaging development lifecycle activities in the Pharma, Medical Device, Food or Cosmetic industry.

 

For this position, you bring the following qualifications:

  • Project management skills and experience in cross-functional projects.
  • Technical expertise in packaging test methods (ISO, USP, and ISTA/ASTM design and validation / qualification), and packaging process and equipment. Sound knowledge of legislation, regulatory and industry standards for packaging.
  • Excellent documentation practices: user requirements, design control, specifications, qualification protocols/reports for packaging systems, risk assessments, and shipping qualification activities.
  • Innovative spirit leading to industry best practices. Design thinking, design management, drives creativity.
  • Knowledge in parenteral primary container and closure systems is a plus.
  • Excellent presentation and interpersonal communication skills.
  • Fosters team effectiveness, team spirit, team alignment, shares risks within the team beyond the function.
  • English language proficiency required.
  • Traveling is required approx. 10-20%

 

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JOB FACTS

Job Sub Category

Manufacturing

Schedule

Full time

Job Type

Regular

Posted Date

Sep 17th 2021

Job ID

202109-126288