Quality Control Technician

Biomedical Production Technician (Cleanroom)

Job Description

The Biomedical Production Technician works in a clean room manufacturing environment to help create biological medical devices derived from porcine liver. This role involves hands-on work with tissue samples, chemical solutions, and sterile processing in a regulated biotech setting. The technician spends most of the day on their feet and regularly lifts bins and livers weighing between 5 and 15 pounds.

The position alternates between build weeks focused on production activities and non-build weeks focused on assembly, documentation, and facility upkeep, offering a consistent full-time schedule with opportunities for overtime and growth into higher-level technician roles.

Responsibilities

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

+ Receive porcine livers and verify materials according to established procedures.

+ Trim porcine livers and prepare tissue samples for further processing.

+ Scoop, measure, and mix chemical solutions used in liver processing, following precise instructions and safety guidelines.

+ Perform decellularization of porcine livers in accordance with standard operating procedures (SOPs) and GMP requirements.

+ Create, cut, and prepare specific tissue pieces for use in medical devices, ensuring accuracy and consistency.

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

+ Follow SOPs and work instructions rigorously to ensure compliance with GMP and regulatory requirements.

+ During non-build weeks, perform assembly tasks related to device production and component preparation.

+ Sweep floors, clean work areas, and perform general housekeeping duties in the clean room and surrounding spaces as needed.

+ Update manufacturing records (MFR paperwork) and maintain accurate documentation of production activities.

+ Support administrative tasks such as order receiving and shipping-related activities as needed.

+ Collaborate with the R&D team and other technicians to support production and development activities.

+ Work directly with porcine livers during production cycles and assist R&D with porcine kidneys during downtime.

+ Maintain strong attention to detail in all aspects of work, including tissue handling, chemical mixing, documentation, and cleaning.

+ Adhere to safety protocols, aseptic techniques, and sterile processing practices to protect product quality and personal safety.

+ Contribute to a small, collaborative team environment and work independently when required to meet production timelines.

Essential Skills

+ Minimum of 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.

+ Demonstrated strong attention to detail, verified through references or prior work experience.

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

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

+ Knowledge of aseptic technique and sterilization procedures.

+ Ability to safely mix and handle chemicals used in biological processing.

+ Comfort working on feet for the majority of the day and lifting 5-15 pound bins and tissue materials.

+ Capability to maintain accurate manufacturing documentation and follow regulated processes.

Additional

Skills & Qualifications

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

Work Environment

This role is based in a new biotech manufacturing facility in Plymouth, MN, where the clean room is being further built out and optimized. The technician joins a small team of three technicians who partner closely with the R&D group, creating a collaborative environment with opportunities to learn and contribute across production and development activities. Work involves direct handling of porcine livers during production cycles and assisting with porcine kidneys during downtime, in a regulated, clean room setting that requires adherence to sterile processing and aseptic techniques.

The production timeline runs from Monday through the following Tuesday, when finished product is shipped out. Production (build) weeks are typically 40+ hours, with mandatory overtime bringing total hours to approximately 42-44 hours. Non-build weeks are around 36 hours. Non-build week hours are generally 8:00 a.m. to 4:30 p.m., Monday through Friday. During build weeks, hours vary:
Mondays run from 8:00 a.m. to 4:30 p.m.;
Tuesdays through Thursdays start between 6:00 a.m. and 6:30 a.m. and end around 4:30-5:00 p.m.;
Fridays start at 7:00 a.m. and typically finish around 1:00-2:00 p.m. The environment is regulated and structured, offering a consistent full-time schedule, some overtime, and the ability to work both independently and as part of a small, focused team in a clean room setting.

Job Type &…