Lab Technician; Med Device

Lab Technician (Med Device)

Job Description

The Lab Technician works in a regulated clean room manufacturing environment to help create biological medical devices derived from porcine liver. This role involves hands-on work with animal tissue, chemical solutions, and sterile processing while following strict SOPs in a GMP setting. The technician spends most of the day on their feet, lifting bins and livers weighing between 5-15 pounds, and contributes to both production (build) weeks and non-production (non-build) weeks as part of a small, collaborative biotech team.

Responsibilities

+ Work in a clean room environment to support the manufacture of biological medical devices derived from porcine liver.

+ Receive porcine livers and verify that materials meet required specifications.

+ Trim porcine livers and prepare tissue samples according to defined procedures.

+ Scoop, measure, and mix chemical solutions used in processing livers, ensuring accuracy and compliance with SOPs.

+ Perform decellularization of porcine livers following established protocols and aseptic techniques.

+ Create, cut, and prepare specific tissue pieces used in device manufacturing.

+ Sterilize and maintain the clean room environment, including equipment and work surfaces, to meet sterile processing standards.

+ Follow SOPs and GMP requirements consistently during all production and documentation activities.

+ Perform assembly tasks in the cleanroom during non-build weeks as part of device manufacturing and support processes.

+ Sweep floors, clean work areas, and complete general housekeeping tasks as needed to maintain a safe and orderly facility.

+ Update and maintain MFR (Manufacturing Record) paperwork and other production documentation accurately and in a timely manner.

+ Assist with administrative tasks, order receiving, and shipping activities as needed to support production timelines.

+ Collaborate with R&D team members, particularly during downtime, to assist with work involving porcine kidneys and other tissue-related tasks.

+ Adhere to production timelines from initial processing through shipment, typically spanning Monday through the following Tuesday.

+ Lift and move bins and livers weighing between 5-15 pounds safely and in accordance with facility guidelines.

+ Participate in mandatory overtime during build weeks to ensure production targets and shipment deadlines are met.

Essential Skills

+ At least 6 months of experience working within a clean room setting.

+ Associate degree in a medical or science-related field.

+ Experience following SOPs in a GMP-regulated environment.

+ Strong attention to detail, with the ability to follow precise instructions and verify information accurately.

+ Hands-on experience with cleanroom practices and sterile processing.

+ Ability to work with tissue samples, including tissue trimming and handling porcine or similar biological materials.

+ Knowledge of aseptic technique and sterilization procedures.

+

Experience with chemical mixing and handling chemicals safely in a production or laboratory environment.

+ Basic understanding of biology or related scientific principles.

+ Ability to stand for most of the workday and safely lift 5-15 pounds repeatedly.

+ Comfort working in a regulated environment with documented processes and quality standards.

Additional

Skills & Qualifications

+ Associate degree in a scientific field such as biology is preferred.

+ Background in roles requiring manual dexterity and attention to detail, such as butcher, barista, quality technician in the food industry, landscaping, or similar positions.

+ Experience in a laboratory setting working with porcine or other animal tissue is highly beneficial.

+ Interest in working in a biotech environment with opportunities to move into Tech II and Tech III roles.

+ Ability to work independently within a smaller group while collaborating effectively with production and R&D teams.

+ Willingness to adapt to varying schedules between build and non-build weeks and to participate in mandatory overtime when required.

Work Environment

This role is based in a new biotech facility in Plymouth, MN, where the clean room is still being built out and refined. The technician works in a regulated clean room environment with a small team of three technicians who closely partner with the R&D group. The work involves direct handling of porcine livers during production weeks and assistance with R&D tasks involving porcine kidneys during downtime.

Production runs follow a timeline from Monday through the following Tuesday, culminating in product shipment. Production (build) weeks typically involve 40+ hours, with some mandatory overtime reaching approximately 42-44 hours. Non-build weeks average around 36 hours. During non-build weeks, the schedule is generally 8:00 a.m. to 4:30 p.m., Monday through Friday. During build weeks, Monday hours are 8:00 a.m. to 4:30 p.m.;
Tuesday through Thursday shifts start between 6:00-6:30 a.m. and end around 4:30-5:00 p.m.;
Friday shifts start at…