Senior Packaging Engineer – Bioengineered Implantables/Top $$ (Relo Option)

Our client, an NC-based biotech that is developing a portfolio of human acellular vessels for the treatment of various vascular conditions including trauma, hemodialysis, peripheral arterial disease, coronary artery bypass grafting and others, is actively recruiting for a highly skilled and knowledgeable Packaging Engineer to join its Manufacturing team.

This is industry-changing technology that is highly anticipated by industry and the medical community. The company is preparing for its first commercial launch and is bringing all packaging processes in-house.  This Engineer will be instrumental in that effort. Compensation will be generous.

Key Things to Note:

• This Engineer will be the Subject Matter Expert on Packaging & Serialization operations and will lead development and implementation for all packaging projects at the site as well as support routine packaging operations. We seek a seasoned Packaging professional who will bring significant expertise and savvy.
• These are first-to-market implantable products that are regulated as biologics. Packaging experience with biologics or similar products will be essential.  Serialization expertise is also critical.
• The company, which engaged CMOs during the clinical production/packaging phase, is bringing all production in-house.  Commercial and scaling experience will be important.
• The vessels are packaged one unit per package. Similar, manual cartoning experience would be valuable.
• This is a publicly-held, well-funded company that, in many ways, operates as a start-up.  Right candidate will be a knowledgeable strategist as well as a hands-on, get-things-done tactician.  Inclination to be resourceful, flexible, adaptable and collaborative will be key.
• This position will be on-site at the company’s RTP area facility.  Company will provide relo for non-local candidates.  COVID vaccinations/boosters are required.

Selected Duties:

• Serve as site subject matter expert through consultation and guidance for packaging operations, including serialization and visual inspection.
• Provide technical oversight for buildout of serialization and final packaging suite.
• Provide technical oversight for packaging materials.
• Lead technical evaluations and specific problem resolution, including troubleshooting and root cause analysis.
• Lead risk assessments of packaging operations and packaging material suppliers.
• Provide expert technical support for all start-up activities (e.g., tech transfer, process validation).
• Provide expert technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability.
• Support and/or lead technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, QPPAs, etc.

Targeted candidate will offer an Engineering Degree (advanced degree desirable) and 6+ years of engineering experience in an FDA/cGMP regulated setting, including substantial expertise in packaging.  Biologics (or closely related) experience will be important. 

Other priorities include:

• Familiarity with technology advances in packaging
• Extensive experience with serialization and related software such as Tracelink
• Experience with manual or automated visual inspection
• Technical transfer experience, including equipment qualification and process validation
• Experience with deviation and change management systems
• Direct experience supporting regulatory audits or inspections
• Professional and congenial communication and interpersonal skills
• Demonstrated ability to prioritize, problem-solve and work through ambiguity, setbacks and change
• History of achievement, growth and longevity

Finally, we seek a positive, focused, and goal-oriented candidate who thrives in a team setting; Someone who is committed to the company’s mission and seeks to contribute broadly and significantly.

This is an exciting opportunity to join a company that is doing exciting work.  There is a lot to do. We seek a go-getter who knows how to get things done.

Please forward resume for prompt consideration.