Laboratory Specialist

Use Your Power for Purpose

The primary purpose of this position is to provide safe and functional product to the market. The main objective is to perform laboratory testing to support the timely implementation of all projects to maintain a consistent supply of our product to the market, while maintaining compliance to lab operation procedures and practices. The individual must be capable of performing testing activities related to the development of materials, packaging and single use components and specifically providing testing expertise to support the development, execution of test methods, and to summarize results.

This position requires versatility on the use of all site laboratory instrumentation and equipment.

What You Will Achieve

• Execute PCE requests, protocols, engineering studies, and validation studies. Prepare eLN and PCE reports and validation documentation.
• Coordinate documentation through the laboratory and ensure accuracy of same while consulting with other members of the laboratory staff and department. Documentation related to test execution includes, but not limited to: requests, notebooks, reports, technical data files, and databases. Assure timely approval by all relevant testing in order to meet overall project milestones.
• Participate on multi-functional teams to identify and resolve product testing issues. Must be able to provide technical resolutions and proofread component specifications and provide input on consistency and accuracy of methods.
• Confirm instrumentation and equipment is properly maintained and calibrated for use. Provide technical support to calibration as needed. Resolve calibration alerts. Maintain training and up to date knowledge on all laboratory equipment and instrumentation.
• Provide technical support for safety initiatives and laboratory audits.
• Maintain laboratory documentation.
• Ensure appropriate materials and products are acquired to conduct testing. Ensure that all materials are properly dispositioned and/or disposed of following the completion of testing.

Here Is What You Need (Minimum Requirements)

• BA/BS with any years of experience
• Laboratory technician/professional requiring the operation and maintenance of instruments or equipment
• Experience in project testing coordination
• Experience operating and maintaining laboratory equipment
• Experience working within a regulated environment
• Experience developing testing methodologies and conducting testing on pharmaceutical container systems, components, and materials.
• Medical product development experience contained in the above items

Bonus Points If You Have (Preferred Requirements)

• A deep understanding of Microbiology testing and experience in defending laboratory practices during regulatory audits
• Proficiency in both viable and non-viable environmental monitoring within pharmaceutical manufacturing
• Solid grasp of aseptic techniques
• Strong problem-solving skills
• Ability to work independently and as part of a team
• Ability to manage multiple tasks simultaneously
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS

The incumbent will be expected to function successfully in a lab and office setting. This individual will be required to work with actual product and packaging systems and may be required to operate pallet-moving equipment and temporarily work in rooms of varied temperature and humidity ranges. The incumbent may be expected to stand for extended periods while conducting testing. In addition, lifting is required but will not exceed human safety limits.

Must be capable of using electronic systems to coordinate testing documentation and record test results.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The use of personal protective equipment, safety goggles, lab coats, hair nets, and gloves may be required for lab entry and also for specific tasks. Minimal travel for test method support, job related training, equipment evaluation, and development should be expected.