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Package Engineer III
Ref No.: 18-11486
Location: South San Francisco, California
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. 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.
Group Responsibilities:
- Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements.
- Develop and qualify global primary, secondary and tertiary packaging solutions
- Qualification of global packaging solutions in line with the current valid requirements (e.g. Development of test protocols and reports, execute IQ, OQ, and PQ etc.)
- Maintenance of global packaging solutions (e.g. maintain global specifications, support change control records, provide impact assessments, execute requalification etc.)

Technical Requirements:
- Knowledge of testing methodologies and test standards including, shock, drop and vibration testing, peel force testing, barrier analysis, CCI/sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation
- Knowledge of packaging equipment, related to non-sterile and sterile packaging activities (e.g. vials, devices, aseptic form/fill/seal, heat sealing, bottle closures, etc.) and printing systems
- Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
- Working knowledge of computer systems including TOPS, CAD or Solidworks, and Microsoft tools including MS project, and Adobe
- Proficient in MS Office Suite including MS Project
- Knowledge of industry best practices