Job Description

Packaging Engineer I

Type : Contract, W2 only

Duration : 12+ months

Location : South San Francisco, CA

Pay : $35/hr-$40/hr, all-inclusive

Please note that at this time we are unable to sponsor employment authorization (both new and transfer)

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.

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 the company's global packaging technology centers

Qualifications:

• Bachelor's 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
• 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

We are an Equal Opportunity Employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based solely on the relevant qualifications, talents, skills, experiences, and business needs

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