Packaging Engineer I
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Job Location:
South San Francisco, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
Key Skills
- Continuous Integration
- Food Industry
- Minitab
- Packaging
- CAD
- Mechanical Knowledge
- Plastics Blow Molding
- SolidWorks
- Mechanical Engineering
- Plastics Injection Molding
- Microsoft Project
- Manufacturing
