QA Engineer Lead/Manager, EQ Validation and Metrology

Terrestrial Bio, Inc.; Woburn (MA); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Quality Assurance Engineer Lead/Manager to oversee the Equipment and Metrology program for its GLP-1 therapy platform. You will manage calibration, maintenance, and qualification of critical equipment and instruments to ensure cGMP compliance.

Reporting to the Head of Quality and Compliance, you will collaborate with Manufacturing, Process Development, QC and Facilities, lead CAPAs, and author SOPs and IQ/OQ/PQ protocols. Onsite in MA with hybrid options.

Qualifications

• BS in Mechanical, Electrical, Chemical engineering or physics, or related field.
• 6+ years (MS 3+ years) in a regulated manufacturing environment (Pharma/Biotech/Medical Device).
• Strong mechanical skills and knowledge of analytical instrumentation and equipment.
• Working knowledge of cGMP and ISO/IEC17025.

Responsibilities

• Oversee calibration schedules and procedures for equipment and instrumentation used in manufacturing and testing.
• Lead root cause investigations and CAPA for deviations.
• Author, review, approve, and revise SOPs and equipment protocols (IQ/OQ/PQ).
• Act as SME on calibration and preventive maintenance with Facilities and QC.

Skills

Mechanical aptitude

Analytical instrumentation knowledge

Measurement systems

Cross-functional collaboration

Education

BS in Mechanical Engineering, Electrical Eng., Chemical Eng., Physics or related

MS in related field (optional)

Tools

SOP writing

IQ/OQ/PQ protocols

cGMP guidance

ISO/IEC17025 knowledge

Job description

About Terrestrial Bio, Inc.

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.

Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more information, visit www.terrestrialbio.com.

Why this role

The Quality Assurance Engineer Lead/Manager role will manage Terrestrial Bio's Equipment and Metrology program in support of the testing and manufacture of Terrestrial's combination products, with a strong focus on the calibration, re-certification, preventative maintenance, and qualification for critical equipment and instruments.

Reporting to the Head of Quality and Compliance, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Facilities by scheduling and/or performing the calibration and preventative maintenance of critical equipment and instruments to ensure critical equipment/instrumentation is operating within expected operating parameters to include qualification for intended use.

What you'll do

• Oversee calibration schedules and procedures for equipment and instrumentation used in the manufacture, testing, and storage of cGMP products.
• Ensure that all work aligns with Good Manufacturing Processes (cGMP), Good Documentation Practices (GDP) and 21 CFR Part 11, Electronic Record Standards as applicable.
• Lead root cause investigations for equipment and analytical instruments deviations and implement Corrective and Preventative Actions (CAPA) as needed.
• Author, review, approve, and revise Standard Operating Procedures (SOPs) and equipment related protocols such as Installation Qualifications, Operating Qualifications, and Performance Qualifications (IQOQPQ).
• Act as the subject matter expert (SME) on the calibration and preventative maintenance of all equipment/instruments partnering with Facilities, Manufacturing and Quality Control to ensure cGMP compliance.

How you'll impact

• Improve, Develop and Manage the Metrology program which may include the management of personnel with the QA Equipment Validation and Metrology Program
• Establish positive relationships across all departments as an advocate for stakeholders to accomplish their agendas.
• Provide professional service oriented support in support of Terrestrial Bio's Quality Assurance objectives.

Who you are

• A minimum of BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Physics, or related technical field required
• Minimum of BS with 6+ / MS with 3+ years working in a regulated manufacturing environment (Pharma, Biotech, or Medical Device)
• Strong mechanical skills and a good grasp of analytical instrumentation, measurement systems, and manufacturing equipment
• Working knowledge of cGMP requirements and International Standards (ISO/IEC17025)

Compensation:

The anticipated base salary range for this position is $100,000 - $140,000 depending on level. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

Onsite expectations:

The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.

Location:

Woburn, MA and our new, custom facility in Allston MA planned for Q4 of 2026.

At Terrestrial, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.