Role: Packaging Engineer
Location: San Francisco, California 94080
Duration: 12 Months (Contract – Possible Extension)
Work Model: Fully Onsite (5 Days/Week)
Position Overview
The Packaging Engineer I will play a key role in developing, qualifying, and maintaining primary and secondary packaging systems for pharmaceutical and combination products. This role supports global packaging development initiatives, ensuring high-quality, compliant, and innovative packaging solutions for both clinical and commercial use.
Key Roles & Responsibilities
Develop and qualify packaging solutions for sterile, non-sterile, and combination products.
Author and co-author packaging specifications, qualification documentation, and reports.
Execute IQ/OQ/PQ and shipping qualifications in alignment with current validation and regulatory standards.
Perform risk assessments, impact analyses, and requalification activities for existing packaging systems.
Evaluate and propose new packaging materials, designs, and technologies to meet product, regulatory, and business requirements.
Support or lead projects implementing innovative packaging systems and technologies.
Maintain documentation and ensure compliance with GMP, GDP, and internal quality systems
Required Education & Qualifications
Bachelor’s degree in Packaging Engineering, Materials Science, Mechanical Engineering, or related field.
1+ years of relevant experience in packaging development or engineering within a regulated industry (pharma, biotech, or medical devices).
Excellent technical, collaboration, and communication skills.
Strong command of English (verbal and written).
Technical Skills & Knowledge
Knowledge of packaging testing methodologies and standards, including:
Shock, drop, and vibration testing
Peel force and tensile testing
Barrier and container closure integrity (CCI/Sterile integrity)
Familiarity with ASTM, ISO, ISTA, USP, FDA, and MHRA standards
Experience with packaging process equipment for sterile and non-sterile products:
Vials, pre-filled syringes (PFS), blister and bottle filling lines, aseptic form/fill/seal, devices
Printing and serialization systems
Proficiency in IQ/OQ/PQ execution and documentation development for packaging and shipping qualifications.
Understanding of design control principles for combination products.
Working knowledge of CAD/SolidWorks, TOPS, MS Project, and Adobe tools.
Strong technical writing abilities and familiarity with industry best practices, GMP, and GDP.
Thanks
Shivam
Email - shivam.awasthi@motionrecruitment.com
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