QA Engineer II – Precision Equipment Validation & Metrology

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

Benefits offered by this job

Hybrid work model

Onsite 4–5 days per week

Job summary

Terrestrial Bio, Inc. is seeking a QA Engineer II to support Equipment Validation and Metrology. You will ensure critical equipment and analytical instruments operate within expected parameters for manufacturing, testing and storage of Terrestrial's products.

Reporting to the QA Manager, you’ll calibrate, verify, and maintain equipment programs, write and review documents, and collaborate with Manufacturing, Process Development, and Quality Control to uphold cGMP standards.

Qualifications

• BS in Mechanical, Electrical, Chemical Engineering, Physics or related technical field.
• 3+ years in a regulated manufacturing environment with BS; 1+ year with MS.
• Strong mechanical skills and knowledge of analytical instrumentation.
• Working knowledge of cGMP and ISO/IEC17025.

Responsibilities

• Oversee calibration schedules and procedures for equipment used in manufacture, testing and storage of cGMP products.
• Ensure all work aligns with cGMP, GDP and 21 CFR Part 11 as applicable.
• Identify root-cause investigations for equipment/analytical deviations and implement CAPA as needed.
• Author, review, approve and revise SOPs and IQ/OQ/PQ protocols.

Skills

Mechanical intuition

Analytical instrumentation

Manufacturing equipment knowledge

cGMP awareness

Education

BS in Mechanical Engineering

MS in Engineering (preferred)

Job description

Terrestrial Bio, Inc. is seeking a QA Engineer II to support Equipment Validation and Metrology. You will ensure critical equipment and analytical instruments operate within expected parameters for manufacturing, testing and storage of Terrestrial's products.

Reporting to the QA Manager, you’ll calibrate, verify, and maintain equipment programs, write and review documents, and collaborate with Manufacturing, Process Development, and Quality Control to uphold cGMP standards.