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Packaging Engineer I

South San Francisco, CA 94080

Posted: 12/27/2022 Employment Type: Contract Job Category: Engineering Job Number: 514588-1 Country: United States Is job remote?: No

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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About South San Francisco, CA

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