Position:Shipping Qualification Engineer, Supply Chain
Location:Brisbane, CA (Hybrid - 3 days onsite)
Length:9+ months
*W2 Candidates Only, No C2C
Job Description:
Our client is seeking a skilled and detail-oriented Shipping Qualification Engineer to join their team. The ideal candidate will have expertise in ensuring the qualification, validation, and compliance of pharmaceutical products during the shipping process. This role requires a strong focus on collaborating with cross-functional teams to ensure that shipments meet regulatory requirements, safety standards, and internal quality protocols. You will play a critical role in maintaining the integrity of pharmaceutical products from the point of manufacturing to delivery, all while adhering to global shipping regulations and industry's best practices.
Essential Duties and Responsibilities (but not limited to):
- Perform qualifications for shipping lanes, packaging, and transportation to ensure compliance with regulatory standards (i.e., GMP, GDP, FDA, IATA).
- Develop and execute qualification protocols for various temperature-controlled products (i.e., CRT, refrigerated, and ultra-cold products), and ensure all commercial shipping processes meet the required environmental specifications.
- Ensure adherence to global shipping regulations and industry best practices, including temperature-controlled shipments and handling guidelines.
- Assist with audits and inspections, prepare and maintain detailed qualification documentation (i.e., validation plans, protocols, reports), and analyze data to recommend process improvements.
- Identify opportunities to improve shipping processes, enhance product quality, and reduce risks.
- Work closely with cross-functional teams (logistics, quality assurance, regulatory) to optimize operations and implement new technologies.
- Provide training and guidance on shipping practices and qualification procedures.
- Investigate and resolve shipping-related issues, such as temperature excursions or delays.
- Ensure compliance with GxP, trade, and tax regulations in all regional supply chain activities.
- Support the shipment of products and materials between various locations.
Qualifications:
- Bachelor's degree (or local equivalent) in a relevant field such as Pharmaceutical Sciences, Engineering, or Supply Chain (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 (i.e., FDA, IATA, EU regulations).
- Familiarity with temperature-controlled shipping processes and equipment (i.e., cold chain logistics).
- Experience with shipping qualification documentation and protocol design.
- Strong analytical, organizational, and problem-solving skills.
- Excellent communication and interpersonal skills, with the ability to collaborate across departments.
- Detail-oriented with a strong focus on maintaining product integrity during shipping.
- Ability to work independently and as part of a collaborative team.
- Experience working in a Quality Management System, preferably Veeva.
- Ability to travel domestically and internationally as required.
- Fluency in English is required (working knowledge of other languages is a plus).
- Certification in Pharmaceutical Packaging or Logistics (i.e., ISPE, PDA) is a plus.
- Experience with shipping software, electronic tracking systems, and data loggers is strongly preferred.
- Knowledge of risk management processes and quality control methodologies is a plus.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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- Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
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Digital Prospectors
Mar 26, 2025