Job Description

Shipping Qualification/ Validation Engineer

Hybrid,-3x a week onsite Brisbane CA

9+ Months

due to the nature of work, W2 Candidates will only be considered

Summary

We are seeking a skilled and detail-oriented Qualification Engineer to join our dynamic team. The ideal candidate will be responsible for ensuring the proper qualification, validation, and compliance of pharmaceutical products during the shipping process. This role involves collaborating with cross-functional teams to ensure all shipments meet regulatory requirements, safety standards, and internal quality protocols. The Qualification Engineer will be critical in maintaining the integrity of pharmaceutical products from the point of manufacturing to delivery.

Requirements: Experience with Shipment Lane validation and qualification activities is required

Language: Fluency in English. Working command of other languages is desirable.

Education: A bachelor’s degree or local equivalent in a related field (Pharmaceutical Sciences, Engineering, Supply Chain). A master’s degree is a plus

Minimum of 3-5 years of experience in pharmaceutical shipping, logistics, or qualification engineering.

• Strong knowledge of GMP, GDP, and relevant regulatory guidelines (FDA, IATA, EU regulations).
• Familiarity with temperature-controlled shipping processes and equipment (e.g., cold chain logistics).
• Experience with shipping qualification documentation and protocol design.
• Excellent problem-solving, analytical, and organizational skills.
• Strong communication and interpersonal skills, with the ability to collaborate across various departments.
• Detail-oriented with a strong focus on maintaining product integrity during shipping.
• Ability to work independently and as part of a team.
• Experience working in a Quality Management System, preferably Veeva.
• Travel: Ability to travel domestically and internationally as required.

Preferred Qualifications:

• Certification in Pharmaceutical Packaging or Logistics (e.g., ISPE, PDA).
• Experience with shipping software, electronic tracking systems, and data loggers.
• Understanding of risk management processes and quality control methodologies.

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