Packaging Engineer I

Packaging Engineer I

Location : South San francisco, CA

Duration : 1 year, extendable

Working Model : Fully onsite (5 days a week)

Objectives & Scope of the position :

This position supports the establishment of a world-class packaging organization by providing technical expertise in the development and deployment of new packaging systems for pharmaceutical products and combination products. The selected candidate will work on a variety of packaging initiatives and will support Global Packaging Development in establishing packaging systems for clinical and commercial use.

Job Responsibilities :

• Develop and qualify global primary and secondary p ackaging solutions for sterile, non-sterile and combination products, incl. author / co-author the related packaging specifications and qualification documentation
• Qualification of global packaging solutions in line with the current validation requirements (e.g. Development of test protocols and reports, risk assessment, execute IQ / OQ / PQ, and shipping qualification)
• Maintenance of global packaging solutions (e.g. support change control records, provide impact assessments, execute requalification)
• Evaluate and develop new materials and / or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements
• Support or lead projects delivering innovative packaging technologies and systems under global packaging technology centers

MUST-HAVE Qualifications :

Knowledge of p ackaging testing methodologies and standards including, shock, drop and vibration testing, peel force and tensile testing, barrier analysis, CCI / Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation