Direct message the job poster from Lean Biologix, LLC
Helping life science manufacturers efficiently meet their goals and mitigate compliance risks
Location: Boston, MA (Onsite/Hybrid/Remote as needed)
About Us:
Lean Biologix is a unique, full-service consulting company supporting FDA-regulated life science manufacturers. We partner with our clients’ internal teams to manage and execute high-impact projects that prioritize both timely delivery and long-term sustainability. By combining deep industry experience with lean principles and smart technology, we help solve our clients’ most pressing challenges efficiently and effectively.
Position Overview:
We’re seeking a Senior level goal-oriented, enthusiastic Validation Engineer to join our growing team. This individual will Lead end-to-end commercial shipping validation projects across global markets, including lane qualification, risk assessment, and protocol/report development for pharmaceutical products. The initial engagement will involve working with a major Boston-based client and their network of service providers to deliver compliant transportation systems and methods.
What We’re Looking For:
* Bachelor’s degree in Mechanical or related engineering discipline
* Minimum of 5 years of experience in pharmaceutical or medical device manufacturing and validaton
* Familiarity with GMP, GDP, and ISTA/ASTM testing procedures
* Strong technical, interpersonal, and communication skills
* Ability to work independently and collaboratively
* Experience with quality management systems and shipping qualifications is a plus
* Proficiency in Microsoft Office (Word, Excel, Project)
Responsibilities:
* Assess shipping methodologies and packaging solutions (Primary, Secondary, Tertiary) for cold-chain distribution
* Serve as a technical liaison with CMOs; and tech transfer teams
* Maintain documentation to ensure compliance and traceability
* Develop and of test protocols to ensure effective and compliant distribution solution with internal stakeholders
* Author and route test reports for approval from test results and data collected
* Communicate with stakeholders to monitor timelines and commercial deadlines
* Oversee material procurement and coordinate testing
* Experience with systems such as Veeva or similar platforms preferred
Why Join Us:
* Competitive compensation and benefits
* Business development opportunities and compensation
* Opportunity to work on impactful projects with leading life sciences companies
* Flexible, collaborative, and purpose-driven culture
* Unlimited PTO program
To Apply:
Send your resume or inquiries to inquiries@leanbiologix.com.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
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