QA Engineer II - Equipment Validation & Metrology (Hybrid)

Terrestrial Bio; Boston (MA); Hybrid; USD 70,000 - 93,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Quality Assurance Engineer II for Equipment Validation and Metrology in Woburn/Allston, MA. The role ensures calibration, maintenance, and documentation for critical manufacturing equipment and analytical instruments, supporting cGMP-compliant production.

This position involves cross-functional collaboration with Manufacturing, Process Development, and Quality Control, with onsite/hybrid work expectations and an emphasis on SOPs, IQOQPQ, and CAPA processes.

Qualifications

• A minimum of BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Physics, or related technical field required.
• Minimum of BS with 3+ / MS with 1+ 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)

Responsibilities

• Assist in the oversight of 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 as applicable.
• Identify and evaluate root cause investigations for equipment and analytical instruments deviations and implement CAPA as needed.
• Author, review, approve, and revise SOPs and equipment related protocols such as IQOQPQ.

Skills

Mechanical skills

Analytical instrumentation

Measurement systems

Manufacturing equipment

Education

BS in Mechanical Engineering

BS in Electrical Engineering

BS in Chemical Engineering

Physics

Job description

Terrestrial Bio, Inc. is seeking a Quality Assurance Engineer II for Equipment Validation and Metrology in Woburn/Allston, MA. The role ensures calibration, maintenance, and documentation for critical manufacturing equipment and analytical instruments, supporting cGMP-compliant production.

This position involves cross-functional collaboration with Manufacturing, Process Development, and Quality Control, with onsite/hybrid work expectations and an emphasis on SOPs, IQOQPQ, and CAPA processes.