Shipping Qualification Engineer

Supply Chain Shipping Qualification Engineer

Long term contract role. Hybrid.

We are seeking a skilled and detail-oriented Shipping 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 Shipping Qualification Engineer will be critical in maintaining the integrity of pharmaceutical products from the point of manufacturing to delivery.

This position is located in Novato, California or Brisbane, California. Flexibility to work from other locations will be considered for extremely qualified candidates.    

Responsibilities  

1. Shipping Qualification & Validation:

a.     Perform qualifications for shipping lanes, packaging, and transportation processes to ensure regulatory compliance (e.g., GMP, GDP, FDA, ANVISA, IATA).

b.     Design, execute, and document shipping qualification protocols and validation studies.

c.      Ensure that all commercial shipping processes are validated and consistently meet the required temperature, humidity, and other environmental specifications for pharmaceutical products.

d.     Develop shipping qualification strategies encompassing Operational and Performance Qualifications for CRT, refrigerated (2 – 8 C) and ultra cold products (<-60C).

e.     Comprehensive understanding of ISTA and ASTM guidelines.

1. Regulatory Compliance:

a.     Stay current with pharmaceutical shipping regulations and industry best practices.

b.     Ensure all shipments adhere to global regulatory requirements, including temperature-controlled shipments, handling guidelines, and security protocols.

c.      Assist with audits and inspections related to shipping qualifications, ensuring compliance with both internal and external audits.

1. Documentation & Reporting:

a.     Prepare user requirements specifications to define basis for design, testing and qualification of the distribution process.

b.     Prepare shipping risk assessments to determine risks associated to the distribution process and required mitigation activities required to lower the identified risks.

c.      Prepare and maintain detailed qualification documentation, including validation plans,  protocols, reports, and validation summaries.

d.     Review and approve shipment qualification documentation, ensuring accuracy and completeness.

e.     Analyze data from shipping qualifications and provide reports and recommendations for process improvements.

1. Process Improvement:

a.     Identify areas of improvement in shipping processes to enhance product quality, reduce risk, and ensure regulatory compliance.

b.     Work with internal teams to implement new shipping technologies, processes, and systems to optimize shipping operations.

1. Collaboration & Training:

a.     Collaborate with logistics, quality assurance, and regulatory teams to ensure smooth coordination and adherence to all pharmaceutical shipping protocols.

b.     Provide training and guidance to team members and stakeholders on proper shipping practices and qualification procedures.

1. Troubleshooting & Problem Solving:

a.     Investigate and resolve any shipping-related issues, including temperature excursions, delays, or damage to pharmaceutical products.

b.     Work closely with vendors and suppliers to address any discrepancies or challenges related to shipping processes.

7.     Compliance:

a.     Ensure compliance with GxP regulations, trade compliance and tax compliance in all areas of the regional supply chains.

8.     Logistics:

a.     Create/Support shipments of product, intermediates, and key starting materials between UGX sites.

Requirements

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

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

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

1. Strong knowledge of GMP, GDP, and relevant regulatory guidelines (FDA, IATA, EU regulations).

1. Familiarity with temperature-controlled shipping processes and equipment (e.g., cold chain logistics).

1. Experience with shipping qualification documentation and protocol design.

1. Excellent problem-solving, analytical, and organizational skills.

1. Strong communication and interpersonal skills, with the ability to collaborate across various departments.

1. Detail-oriented with a strong focus on maintaining product integrity during shipping.

1. Ability to work independently and as part of a team.

1. Experience working in a Quality Management System, preferably Veeva.

12.  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.