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Packaging Engineer III
Ref No.: 18-01205
Location: South San Francisco, California
Job Title: Packaging Engineer III
Job Company: Major BioPharma
Job Category: Engineering / Design Support
Job Location: South San Francisco, CA
Job Duration: 1 year contract; Multiple openings!

Job Description:

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

Experience:
  • At least 2 years’ experience in relevant field
  • Proficient technical leadership, collaboration and communication skills
 
Education:
  • Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field