Packaging Engineer ROCGJP00019397 

A leading biotechnology company is looking for a Packaging Engineer. The successful candidate will work on a variety of packaging initiatives and will support Packaging Engineering in establishing packaging systems for clinical and commercial use. The ideal candidate has a working knowledge of computer systems including TOPS, CAD or Solidworks, and Microsoft tools including MS project, and Adobe.

Packaging Engineer Pay and Benefits:

• Hourly pay: $30-$40/hr
• Worksite: Leading biotechnology company (South San Francisco, CA 94080, 5% of travel required) 
• W2 Employment, Group Medical, Dental, Vision, Life, 401k, PSL
• 40 hours/week, 12 Month Assignment 

Packaging Engineer Responsibilities: 

• Develop and qualify global primary and secondary packaging solutions for sterile, non-sterile, and combination products, incl. author/co-author of 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.
• Support 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. 

Packaging Engineer Qualifications: 

• 2 years of working experience in a relevant field.
• Bachelor's degree, preferably with an engineering degree in packaging, materials science, or a related field.
• 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 of equipment IQ, OQ, and PQ and development of qualification protocols/reports for packaging and shipping qualification activities.
• Knowledge of design control for combination products.
• Proficient technical leadership, collaboration, and communication skills.
• English language proficiency required.
• 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.