QA Engineer Lead, Metrology & Equipment Validation

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

Job summary

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

We are seeking a Quality Assurance Engineer Lead/Manager to manage the Equipment and Metrology program, calibrating critical instruments and ensuring cGMP compliance across manufacturing and QA functions. Reporting to the Head of Quality and Compliance, you will drive CAPA investigations, author SOPs, and shepherd IQOQPQ activities with cross-functional teams.

Qualifications

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

Responsibilities

• 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 cGMP, GDP and 21 CFR Part 11 Electronic Records Standards as applicable.
• Lead root cause investigations for equipment deviations and implement CAPA as needed.
• Author, review, approve, and revise SOPs and equipment-related IQOQPQ protocols.
• Act as SME on calibration and preventative maintenance partnering with Facilities, Manufacturing and Quality Control.

Skills

mechanical skills

analytical instrumentation

measurement systems

manufacturing equipment

Education

BS in Mechanical Engineering

MS in related field

Job description

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

We are seeking a Quality Assurance Engineer Lead/Manager to manage the Equipment and Metrology program, calibrating critical instruments and ensuring cGMP compliance across manufacturing and QA functions. Reporting to the Head of Quality and Compliance, you will drive CAPA investigations, author SOPs, and shepherd IQOQPQ activities with cross-functional teams.