Packaging Technician I

Integra Lifesciences Holdings Corporation • Columbia, MD

126d

About The Position

The Packaging Lab Technician I is responsible for participating in all aspects of package testing for the development of medical devices at Integra in compliance with applicable regulatory Quality System Requirement. These duties include characterizing medical device packaging designs and prototypes, working on new process methodologies, performing specific laboratory techniques, and participating in validations and equipment maintenance and calibrations. The Packaging Lab Technician I will work alongside other technicians, performing testing and other duties according to Integra's 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 laboratory data sheets, a test report or in a laboratory notebook detailing experimental work. As a member of the Process Technology group, the Packaging Lab Technician I position is trained in standard testing methods in accordance with industry standards. These methods may involve testing in support of the qualification of packaging systems, packaging sealing equipment and root cause investigation and exploratory testing. In these duties and others, maintaining a safe working environment is required. The Packaging Lab Technician is also responsible for laboratory housekeeping. These duties may include cleaning laboratory workspaces along with duties related to the upkeep and dusting of laboratory test equipment, instruments, and common areas.

Requirements

• High school diploma required or GED equivalent.
• Preferably, 3+ years working in a lab 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.
• 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.
• Organization and time management skills are highly recommended.
• Ability to work regularly and predictably.
• Proficiency with math, the metric system, weight, and volume.
• MS Office.
• Fluent in English (speaking and writing).

Responsibilities

• Perform physical mechanical testing on medical device packaging systems per the specified test plan and/or SOP, and operation of respective equipment for each test.
• Documentation of the test results in a format specified which includes supplied datasheets, handwritten datasheets, and computer printouts.
• Completion of data sheets and other documentation using Good Documentation Practices (GDP), with keen attention to details.
• Attention to the timely and accurate execution of test procedures with minimal supervision.
• Maintain a functional, safe, and effective laboratory and ensure that all equipment meets standards for laboratory research use.
• Participates in the planning of the laboratory workload to ensure tasks and objectives are completed and collaborates as a participative team member to ensure R D milestones are met.
• Generate test reports and compile datasheets and other test evidence to be presented to requestor/ team for review/ approval.
• Communication with supervisor and/or project managers on testing status.
• 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.
• Maintain proper documentation of all studies and testing performed following cGDP guidelines.
• Participate in inventory control and ensure items are ordered through the appropriate supplier.
• Perform other duties as assigned.

Benefits

• Equal employment opportunities regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
• Commitment to provide reasonable accommodations for disabled veterans or individuals with disabilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Management of Companies and Enterprises
• Education Level: High school or GED