Position Details
Packaging Engineer I Apply
Packaging Engineer I
Location: South San francisco, CA
Duration: 1 year, extendable
Duration: 1 year, extendable
Working Model: Fully onsite (5 days a week)
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:
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 under global packaging technology centers
MUST-HAVE Qualifications:
- 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
