Packaging Engineer I Job at Sharp Decisions, South San Francisco, CA

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  • Sharp Decisions
  • South San Francisco, CA

Job Description

Title - Packaging Engineer I

Pay Rate: $40.60/hr

Location: South San Francisco, California, 94080 United States - Onsite

Interview Format: Two rounds (Virtual - 1st round 30 minutes; 2nd round 60 minutes)

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 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

Education & Qualifications:

  • Personal Requirements: 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 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, 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

Job Tags

Work experience placement,

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