Lean Biologix is a unique full-service consulting company focused on FDA regulated life science manufacturers. We collaborate with our clients’ internal resources to manage and execute projects that have a lasting impact. We provide on-time delivery and focus not only on project completion but sustainability. We leverage technology and lean principles to deliver efficient and manageable solutions to our clients’ most pressing problems.
We currently have an immediate opening for a goal oriented and enthusiastic Engineer. The ideal candidate will have a minimum of a BS in Engineering and a minimum of 2 years’ experience within Life sciences manufacturing. Knowledge of supply chain distribution, Validation, and GMP shipping requirements a plus.
This position will work closely with various clients to support clinical and commercial programs, as well as work with affiliated manufacturers and distributors to define and maintain distribution compliance with industry standards and regulations.
The position will require not only technical skills but good interpersonal and communication and project management skills. This position also requires a person that can work independently but can work well with others and collaborate as a team member.
The position offers competitive compensation and benefits including healthcare and matching 401(k).
- Support supply chain initiatives relating to packaging, cold-chain distribution and monitoring
- Develop testing strategies and technical documentation (plans, protocols, reports, and procedures)
- Lead qualification activities relating to product packaging, temperature control and monitoring throughout the supply lanes
- Support tech transfer for client sites, CMOs and distribution partners
- Manage cross-functional teams to monitor project timelines and status to ensure project deliverables are met in support of regulatory filing deadlines
Preferred Qualifications & Experience:
- BS degree in Engineering discipline
- 2 plus years of experience working in the Life Sciences industry
- Experience relating to GDP and GMP and Quality management systems
- Experience in shipping qualifications a plus
- Hands-on approach to problem solving, risk identification and resolution
- Excellent Microsoft Office skills (Word, Excel, Project)
- Ability to work on multiple projects simultaneously / adjust workload based on priorities