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 Packaging Engineer. The ideal candidate will have a minimum of either a BS in Packaging Engineering or a BS in other engineering discipline and a minimum of 5 years experience with Pharmaceutical or Medical device packaging and labeling. Knowledge of ISTA/ASTM testing procedures and GMP requirements a plus.
This position will work closely with various clients in an effort to support clinical and commercial programs as well as work with our affiliated manufacturers and testing partners to define and implement packaging and labeling solutions that are compliant with industry standards and regulations.
The position will require not only technical skills but good interpersonal and communication 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.
- Label and packaging development and qualification (Primary, Secondary and Tertiary) for various temperature applications
- Develop testing strategies and protocol documentation
- Lead qualification activities for product labeling and packaging that requires temperature control throughout various supply lanes
- Work with vendors to optimize packaging and labeling solutions based on client requirements
- Communicate with internal stakeholders to monitor project timelines, status to ensure project deliverables are met in support of regulatory filing deadlines
- Coordinate material procurement and testing oversight
- Generate test reports based on resulting test data
Preferred Qualifications & Experience:
- BS degree in Packaging or other Engineering discipline
- 5 plus years of experience relating to labeling and packaging within the medical industry
- Experience relating to GDP and GMP and Quality management systems
- Experience in shipping qualifications a plus