Packaging Engineer

  • Contract
  • Anywhere

Job Title: Packaging Engineer
Location: South San Francisco
Duration: 12 Months

Job Responsibilities:

  • Develop and qualify global primary and secondary packaging 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 Roche global packaging technology centers

Technical Requirements:

  • Knowledge of packaging 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
  • Knowledge of packaging process equipment, related to sterile, non-sterile, and combination products packaging activities (e.g., vials, PFS, devices, aseptic form/fill/seal, blister and bottle filling lines), printing systems and serialization
  • Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
  • Knowledge of design control for combination products
  • Working knowledge of computer systems including TOPS, CAD or Solid works, and Microsoft tools including MS project, and Adobe
  • Knowledge of industry best practices and technical writing skills such as GMP and GDP

Education & Qualifications:

  • Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field
  • At least 2 years’ working experience in relevant field
  • Proficient technical leadership, collaboration and communication skills
  • English language proficiency required

Job # 22-00929

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