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Salary: USD 100,000 - 140,000 / annual
Terrestrial Bio is seeking a QA Engineer Lead/Manager to oversee the Equipment and Metrology program supporting the testing and manufacturing of its Tacterra™ microarray patch platform—a next-generation drug delivery system for GLP-1 and other therapeutics. Reporting to the Head of Quality and Compliance, you will manage calibration, re-certification, preventative maintenance, and qualification of critical equipment and instruments used in cGMP manufacturing and testing environments.
Key responsibilities include: overseeing calibration schedules and procedures for all manufacturing and testing equipment; ensuring compliance with cGMP, GDP, and 21 CFR Part 11 standards; leading root cause investigations for equipment deviations and implementing CAPA; authoring, reviewing, and approving SOPs and qualification protocols (IQ/OQ/PQ); and serving as the subject matter expert on calibration and preventative maintenance across the organization.
You will work cross-functionally with Manufacturing, Process Development, Quality Control, and Facilities teams to ensure all critical equipment operates within expected parameters and is qualified for intended use. You may manage personnel within the QA Equipment Validation and Metrology Program and will establish positive stakeholder relationships across departments.
Required qualifications: BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Physics, or related technical field; minimum 6+ years (BS) or 3+ years (MS) in regulated manufacturing (pharma, biotech, or medical device); strong mechanical skills and knowledge of analytical instrumentation, measurement systems, and manufacturing equipment; working knowledge of cGMP requirements and ISO/IEC 17025 standards.
The role is hybrid with onsite expectations of 4–5 days per week at Woburn, MA, with a planned relocation to a new custom facility in Allston, MA in Q4 2026.