Job Description
We are seeking a Supply Chain Shipping Qualification Engineer for a Full-Time Contract Opportunity in Brisbane, CA or Novato, CA. The Supply Chain Shipping Qualification Engineer will be responsible for, but not limited to;
- Shipping Qualification & Validation
- Perform qualifications for shipping lanes, packaging, and transportation processes to ensure regulatory compliance (e.g., GMP, GDP, FDA, ANVISA,IATA)
- Design, execute, and document shipping qualification protocols and validation studies
- Ensure that all commercial shipping processes are validated and consistently meet the required temperature, humidity and other environmental specifications for pharmaceutical products
- Develop shipping qualification strategies encompassing Operational and Performance Qualifications for CRT, refrigerated (2-8C) and ultra cold products (<-60C)
- Regulatory Compliance
- Stay Current with pharmaceutical shipping regulations and industry best practices
- Ensure all shipments adhere to global regulatory requirements, including temperature-controlled shipments, handling guidelines, and security protocols
- Assist with audits and inspections related to shipping qualifications, ensuring compliance with both internal and external audits
- Documentation & Reporting
- Prepare user requirements specifications to define basis for design, testing and qualification of the distribution process
- Prepare shipping risk assessments to determine risks associated to the distribution process and required mitigation activities required to lower the identified risks
- Prepare and maintain detailed qualification documentation, including validation plans, protocols, reports and validation summaries
- Review and approve shipment qualification documentation, ensuring accuracy and completeness
- Analyze data from shipping qualifications and provide reports and recommendations for process improvements
- Process Improvement
- Identify areas of improvement in shipping processes to enhance product quality, reduce risk, and ensure regulatory compliance
- Work with internal teams to implement new shipping technologies processes, and systems to optimize shipping operations
- Collaboration & Training
- Collaborate with logistics, quality assurance, and regulatory teams to ensure smooth coordination and adherence to all pharmaceutical shipping protocols
- Provide training and guidance to team members and stakeholders on proper shipping practices and qualification procedures
- Troubleshooting & Problem Solving
- Investigate and resolve any shipping-related issues, including temperature excursions, delays, or damage to pharmaceutical products
- Work closely with vendors and suppliers to address any discrepancies or challenges related to shipping processes
- Compliance
- Ensure compliance with GxP regulations trade compliance and tax compliance in all areas of the regional supply chains
- Logistics
- Create/ Support shipments of product, intermediates, and key starting materials between sites
Requirements
- Language: Fluency in English. Working command of other languages is desirable
- Education: 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 strong focus on maintaining product integrity during shipping
- Ability to work independently and as a 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
Job Tags
Full time, Contract work, Local area,