Packaging Engineer/Sr. Packaging Engineer

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. This position supports the establishment of a world class Global Packaging Development organization by applying technical leadership and expertise in the development, qualification, and deployment of new packaging systems for small molecule, parenteral, gene therapy and combination products. The success of this position requires effective collaborations and trusted relationships with Pharmaceutical Development, External Manufacturing, Marketing, Supply Chain, Packaging Operations, Regulatory, etc.

General 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 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 this position, you bring the following qualifications:

• Bachelor degree in materials science, packaging engineering, mechanical engineering or related field; with a minimum of 5+ years with Bachelors (or 3+ yrs w/ Masters) working in packaging development lifecycle activities in the Pharma, Medical Device, Food or Cosmetic industry.

• Technical expertise in packaging design, test methods and packaging equipment and process qualification / validation.

• Sound knowledge of legislation, regulatory guidance and industry standards for packaging (e.g. ISTA/ASTM, design and validation / qualification, ISO, USP/EU/JP Compendia, ICH, and 21 CFR Part4).

• 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.

Preferred:

• Project management skills and experience in cross-functional projects.

• Fosters team effectiveness, team spirit, team alignment, shares risks within the team beyond the function.

• Traveling is required approximately 10-20%.

This position is an on-site position and located at the US Headquarters of Genentech in South San Francisco, CA.

Relocation benefits are not available for this posting.