Job Description

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:

• Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field
• At least 1 year working experience in relevant field
• Proficient technical leadership, collaboration and communication skills
• English language proficiency required
• Technical Requirements:
  • 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
  • Knowledge of packaging process equipment, related to steriles, and 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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