Shipping Validation Engineer

Location: Greater Boston area, Hybrid/On-siteCompany: Lean Biologix, LLC.Employment Type: Full-TimeAbout Lean BiologixLean Biologix is a premier compliance and engineering consulting firm serving life science clients across pharmaceuticals, biologics, and cell & gene therapy. We help our clients navigate the complexities of regulatory requirements and technical operations with innovative, science-driven solutions. Our team is passionate about ensuring the safety, quality, and performance of therapies that change lives.Position SummaryWe are seeking a motivated and detail-oriented Shipping Validation Engineer I to support our growing validation team. In this role, you will assist in the design, execution, and documentation of commercial shipping validation activities for temperature-sensitive products. This is an excellent opportunity for a recent graduate or early-career professional to gain hands-on experience in a high-impact, regulated industry while being mentored by experienced engineers and consultants.Key ResponsibilitiesSupport the development and execution of shipping validation protocols, including lane qualifications, pack-out testing, and performance monitoring.Assist in data collection, analysis, and reporting for temperature-controlled shipping systems (2–8°C, CRT, frozen, cryogenic).Help coordinate validation studies with supply chain, packaging, and quality assurance teams.Review and interpret data loggers and environmental monitoring data for shipping excursions.Contribute to the creation and maintenance of validation documentation in accordance with regulatory and quality standards (FDA, EMA, ICH, USP, WHO).Ensure compliance with Good Distribution Practices (GDP) and internal SOPs.Participate in client meetings and project updates under the supervision of senior team members.QualificationsBachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field.1–2 years of experience in a regulated environment (internships or co-ops in pharma/biotech/logistics a plus).Strong interest in cold chain, packaging, logistics, supply chain validation.Familiarity with basic validation concepts, data analysis, or regulatory frameworks is preferred.Detail-oriented with strong organizational and documentation skills.Proficient in Microsoft Office (Word, Excel, PowerPoint); experience with data logging tools or software a plus.Team player with a willingness to learn and take initiative.Ability to be onsite in the greater San Francisco Bay area to support client testing.Why Start Your Career with Lean Biologix?Gain valuable experience in a high-demand field with mentorship from industry experts.Contribute to mission-critical work supporting the commercialization of advanced therapies.Access a flexible, collaborative, and supportive work environment.Opportunities for professional development and career advancement.Competitive compensation and benefits package.Ideal CandidateOur ideal candidate is an curious, fast learning engineer willing to take on new challenges and learn new skills. This person must be an outgoing individual who works well in team settings as well as the ability to manage their unsupervised time effectively. This person must have a professional attitude and present well in client facing situations.