cGMP Technician, Med Device Product Development

Terrestrial Bio, Inc.; Walnut Hill (MA); On-site; USD 34,000 - 41,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a hands-on manufacturing professional to operate cGMP medical device processes and execute batch records for our MAP-based therapy platform.

You will work with assembly equipment, conduct in-process testing, and contribute to product development investigations in a regulated biotech environment. Ideal candidates have 2+ years in a regulated setting, strong lab technique, and the ability to thrive in both lab and cleanroom spaces.

Qualifications

• 2+ years in a regulated environment (chemical, biotech, medical device, or biopharmaceutical).
• High school diploma required; associate degree or trade cert preferred.
• Strong lab technique with attention to detail and ability to work independently.

Responsibilities

• Perform cGMP medical device operations according to documented procedures and batch records.
• Operate device assembly and testing equipment—custom assembly fixtures, mechanical testers, laser displacement sensors and controllers, dimensional measurement equipment.
• Complete batch records, logbooks, and test records following Good Documentation Practices.
• Run in-process testing: visual inspection, physical and mechanical testing.
• Contribute to root cause analyses and product development investigations.
• Review documentation for completeness and regulatory compliance.
• Support process and product development efforts as needed—design control, test method development, in vivo and ex vivo experiments, custom fixture design, and prototyping.
• Follow all safety guidelines—PPE, chemical handling, emergency procedures.

Skills

Lab technique

Mechanical testing

Weighing

Visual inspection

Dimensional measurement

CAD

3D printing

Statistical analysis

Education

High school diploma

Associate’s degree

Trade certification

Tools

CAD

3D printing

Job description

Terrestrial Bio, Inc. is seeking a hands-on manufacturing professional to operate cGMP medical device processes and execute batch records for our MAP-based therapy platform.

You will work with assembly equipment, conduct in-process testing, and contribute to product development investigations in a regulated biotech environment. Ideal candidates have 2+ years in a regulated setting, strong lab technique, and the ability to thrive in both lab and cleanroom spaces.