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Packaging Engineer I

South San Francisco, CA 94080

Posted: 09/15/2022 Employment Type: Contract Job Category: Engineering Job Number: 514588 Is job remote?: No Country: United States

Job Description


Description:

Objectives and Scope of 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 Packaging Engineering in establishing packaging systems for clinical and commercial use.

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

Qualifications

Education & Qualifications:

Personal Requirements:
  • 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

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 steriles, non-steriles, 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 Solidworks, and Microsoft tools including MS project, and Adobe
  • Knowledge of industry best practices and technical writing skills such as GMP and GDP
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