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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.
Job Requirements
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 printoutsCompletion of data sheets and other documentation using Good Documentation Practices (GDP), with keen attention to detailsAttention 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 useParticipates 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 statusConduct multiple projects under tight timelinesRepackaging of the test samples after testing is completeShipping and receiving of samples and test materials as necessaryMaintain proper documentation of all studies and testing performed following cGDP guidelinesParticipate in inventory control and ensure items are ordered through the appropriate supplierPerform other duties as assignedAdditional Responsibilities
Assist in ensuring that laboratory equipment is in a calibrated state throughout the year according to manufacturer’s recommendations and Integra procedures and guidelinesDevelopment of standard operating procedures and specificationsAbility to independently investigate and solve technical problems, as necessaryAssist with the training of new technicians within the laboratoryAssist in the improvement of protocols and processes in the laboratoryInventory management and ordering of reagents and suppliesDESIRED MINIMUM QUALIFICATIONS
High school diploma required or GED equivalentPreferably, 3+ years working in a lab setting or medical device environment with experience following strict safety standards, or equivalent education and experienceAuthorization to work in the United States indefinitely without restriction or sponsorshipRequired Knowledge, Skills, and Abilities
Customer Service oriented, excellent communication (oral and written) and attention to detailsStrong computer, scientific, and organizational skillsGood understanding of cGMPs, industry and regulatory standard and guidelinesGood understanding of federal and local regulations regarding health and safety within a manufacturing and laboratory environment.Organization and time management skills are highly recommendedAbility to work regularly and predictablyProficiency with math, the metric system, weight, and volumeMS OfficeFluent in English (speaking and writing)TOOLS AND EQUIPMENT USED
Office equipment: Computer (desktop or laptop), keyboard, mouse, desk, chairMeasurement tools: (ruler, calipers)Cutting tools: scissors, precision knife, box cutterPackaging equipment: Vibration table, drop tester, compression tester, leak detector, tensile tester,PHYSICAL REQUIREMENTS
Ability to sit for extended periodsMust be able to push, pull, squat, bend, and reach above shouldersRepetitive use of handsAbility to work on computer for extended periodsAbility to lift up to 50 lbs.Ability to work in a laboratory environment, including meeting OSHA and cGLP requirements.Repetitive use of handsIntegra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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