Packaging Technician II

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Packaging Lab Technician II works independently, performing testing and other duties according to standard operating procedures. Tasks are directed by Packaging Engineers and R&D staff, though some projects will be self-directed. All testing is documented through standard procedures or in a laboratory notebook detailing experimental work.

As a member of the Process Technology group, the Packaging Lab Technician II is trained on standard test methods used se methods may involve flexible and rigid packaging, packaging sealing equipment and packaging performance testing equipment. In these duties and others, attention to safety is required.

The Packaging Lab Technician II is also responsible for overseeing laboratory housekeeping. These duties include cleaning of laboratory spaces and classified (clean room) spaces along with duties related to the upkeep and cleaning of laboratory equipment, instruments, and common laboratory areas.

* Typical work hours: M-F 8:30AM-5:00pm and/or 9:00-5:30pm ET as needed

• Maintain a functional, safe, and effective laboratory and ensure that all equipment meets standards for laboratory testing use
• Perform mechanical testing on medical device packaging systems per the specified test plan and/or SOP, and operation of respective equipment for each test.
• Document the test results in a format specified which includes handwritten datasheets, computer printouts, and electronic data entry.
• Understand the importance of maintaining the integrity of the test and subsequent data of each test performed.
• Demonstrate effective communication skills through:
  • Facilitate communication between the laboratory and customers (internal) regarding testing requirements, status, and outcome.
  • Communication with supervisor and/or project managers on testing status.
  • Document the test results in a format specified which includes handwritten datasheets, computer printouts, and electronic data entry.
• Develop and demonstrate skills in summarizing data to key stakeholders, maintaining databases and supporting laboratory priorities
• Completes assignments and facilitates the work activities of others, may coordinate work beyond own area.
• Attention to the timely and accurate execution of test procedures with minimal supervision.
• Works autonomously within established procedures and practices, proposing improvements to processes and methods as needed.
• Providing subject matter guidance to more junior team members
• Prioritize various test requests to ensure tasks and objectives are completed and collaborate as a participator team member to ensure R&D milestones are met.
• Provide inputs for test related deviations, non-conformances, or out of specification (OOS)
• Implement and oversee the On-The-Job (OTJ) and/or test method validations as part of training of new lab technicians
• Must have good organizational skills and be able to conduct multiple projects under tight timelines
• Repackaging of the test samples after testing is complete
• Shipping and receiving of samples and test materials as necessary
• Ability to independently investigate and solve technical problems, as necessary
• Maintain proper documentation of all studies and testing performed following Good Documentation Practices (cGDP) guidelines
• Participate in inventory control and ensure items are ordered through the appropriate supplier
• Perform other duties as assigned

• High School Diploma, Vocational, Certification or equivalent with 5+ years of experience
• Preferably, 3+ years working in an analytical or mechanical laboratory setting or medical device environment with experience following strict safety standards, or equivalent education and experience
• Authorization to work in the United States indefinitely without restriction or sponsorship

• Assist in ensuring that laboratory equipment is in a calibrated state throughout the year according to manufacturer’s recommendations and Integra procedures and guidelines
• Develops, authors test reports, standard operating procedures (SOPs), and specifications
• Assist in the improvement of protocols and processes in the laboratory
• Inventory management and ordering of reagents and supplies

• Customer Service oriented, excellent communication (oral and written) and attention to details
• Strong computer, scientific, and organizational skills
• Good understanding of cGMPs, industry and regulatory standard and guidelines
• Good understanding of federal and local regulations regarding health and safety within a manufacturing and laboratory environment.
• Experience with…