Packaging Lab Technician II

Integra LifeSciences•Columbia, MD

1d•Onsite

About The Position

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 the Packaging Laboratory Manager or designee, 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 Packaging Team, the Packaging Lab Technician II is trained on standard test methods used at Integra. These 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 and inventory management. 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; as well as ensuring there is stock of materials used daily or project-specific.

Requirements

High School Diploma, Vocational, Certification or equivalent with 5+ years of experience
3+ years working in a mechanical laboratory setting or medical device environment with experience following strict safety standards, or equivalent education and experience is preferred.
At least 1 year experience in a Packaging laboratory setting
Proficiency in Microsoft Office (Word, Excel, Power Point and Outlook, at minimum)
Authorization to work in the United States indefinitely without restriction or sponsorship
Comfortable with the daily use of personal protective equipment (e.g. lab coat, safety glasses and/or steel toe shoes/caps)
Strong computer, laboratory, and organizational skills
Familiarity with the use of software to operate equipment
Good understanding of cGMPs, industry and regulatory standard and guidelines
Good understanding of federal and local regulations regarding health and safe work practices within a manufacturing and laboratory environment.
Proficient in operating, maintaining and troubleshooting automated packaging equipment
Proficiency with math, the metric system, weight, and volume
Customer Service and Quality-oriented, excellent communication (oral and written) and attention to details
Ability to work Monday through Friday onsite
Fluent in English (speaking and writing)

Nice To Haves

Knowledge of packaging equipment and procedures is preferred
Experience with statistics, experimental design, and multivariate analyses (and their related software) is a plus

Responsibilities

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 specified format 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: Facilitating communication between the laboratory and customers (internal) regarding testing requirements, status, reporting, and timeline. Communication with supervisor and/or project managers on testing status and any issues encountered during the test request. Timely notification of testing delays, issues with samples, or changes in schedule.
Develop and demonstrate skills in compiling, analyzing, and summarizing data to key stakeholders as well as maintaining databases by using MS Office tools (e.g. Excel), preparing reports and/or presentations to support decision-making.
Completes assignments and facilitates the work activities of others, may coordinate work beyond own area.
Coordination of testing execution and 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.
Provide inputs for test related deviations, non-conformance's, or out of specification (OOS) results.
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
Ability to repack 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 in a timely manner
Responsible for maintaining equipment in the lab by ensuring all equipment is in a calibrated state, ready to use and qualified prior to use
Ability to develop an operational and method specific procedure independently
Lead and collaborate with peers on the restructure of laboratory processes, workflow and sample storage logistics to streamline processes as part of 6S initiatives
Perform other duties as assigned
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 and authors test reports, standard operating procedures (SOPs), and specifications when needed
Lead and/or assist in the improvement of protocols and processes in the laboratory
Inventory management and ordering of reagents and supplies