Packaging Engineer INaderi Engineering, Inc. • South San Francisco, CA, US

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Packaging Engineer I

Naderi Engineering, Inc. • South San Francisco, CA, US

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Job Description

Job No. ROCGJP00038410

Client : Genentech

Contract Duration : 1 Year

Rate : $35 - $40 / hr.

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 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 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 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

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