QA Engineer II: Precision Equipment Validation & Metrology

Terrestrial; Woburn (MA); On-site; USD 70,000 - 93,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Quality Assurance Engineer II focused on Equipment Validation and Metrology in a regulated manufacturing environment.

The role collaborates with Manufacturing, Process Development, and Quality Control to ensure instruments and equipment operate within validated parameters throughout production. The position emphasizes calibration oversight, GMP compliance, and documentation excellence, with onsite or hybrid work and a base salary aligned to manufacturing

Qualifications

• BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Physics, or related technical field is required.
• 3+ years (MS 1+ year) in a regulated manufacturing environment (Pharma/Biotech/Medical Device) preferred.

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, Electronic Record Standards as applicable.
• Identify and evaluate root cause investigations for equipment and analytical instrument deviations and implement CAPA as needed.
• Author, review, approve, and revise SOPs and equipment-related protocols such as IQ,OQ,PQ.

Skills

Mechanical skills

Analytical instrumentation

Measurement systems

Manufacturing equipment

cGMP knowledge

ISO/IEC17025 familiarity

Education

BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Physics, or related technical field

BS with 3+ years / MS with 1+ years in regulated manufacturing (Pharma, Biotech, or Medical Device)

Tools

Job description

Terrestrial Bio, Inc. is seeking a Quality Assurance Engineer II focused on Equipment Validation and Metrology in a regulated manufacturing environment.

The role collaborates with Manufacturing, Process Development, and Quality Control to ensure instruments and equipment operate within validated parameters throughout production. The position emphasizes calibration oversight, GMP compliance, and documentation excellence, with onsite or hybrid work and a base salary aligned to manufacturing