QA Engineer II - Equipment Validation & Metrology

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

Job summary

Terrestrial Bio, Inc. in Massachusetts is seeking a Quality Assurance Engineer II for Equipment Validation and Metrology.

You will help ensure that critical equipment and analytical instruments operate within spec to support manufacturing, testing and storage of Terrestrial's combination products. Reporting to the QA Manager, you will perform calibration verifications, maintenance, log equipment usage, and write or revise related documents, SOPs and qualification protocols.

Qualifications

• Requires a BS/MS in an engineering/technical field with experience in regulated manufacturing environments.
• Strong mechanical skills and familiarity with analytical instrumentation and measurement systems.
• Working knowledge of cGMP requirements and ISO/IEC17025.
• Experience with calibration, validation, and quality systems is preferred.

Responsibilities

• Oversee calibration schedules and procedures for equipment and instrumentation used in the manufacture, testing, and storage of cGMP products.
• Ensure that work aligns with cGMP, GDP and 21 CFR Part 11 Electronic Records Standards.
• Identify root cause deviations and implement CAPA as needed.
• Author, review, approve, and revise SOPs and IQ/OQ/PQ/related protocols.

Education

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

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

Job description

Terrestrial Bio, Inc. in Massachusetts is seeking a Quality Assurance Engineer II for Equipment Validation and Metrology.

You will help ensure that critical equipment and analytical instruments operate within spec to support manufacturing, testing and storage of Terrestrial's combination products. Reporting to the QA Manager, you will perform calibration verifications, maintenance, log equipment usage, and write or revise related documents, SOPs and qualification protocols.