QA Engineer II, EQ Validation and 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

About Terrestrial Bio, Inc.

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

Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more information, visit www.terrestrialbio.com.

Why this role

The Quality Assurance Engineer II for Equipment Validation and Metrology will assist in assuring that all of Terrestrial Bio's critical Equipment and Analytical Instruments are operating within expected parameters in support of the manufacture, testing, and storage of Terrestrial's combination products.

Reporting to the Quality Assurance Manager of Equipment Validation and Metrology, this role works cross-functionally with Manufacturing, Process Development, and Quality Control by performing/reviewing calibration verifications and preventative maintenance, maintain equipment usage logs, and write, revise, review and approve equipment related documents and data.

What you'll do

• Assists 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 Good Manufacturing Processes (cGMP), Good Documentation Practices (GDP) and 21 CFR Part 11, Electronic Record Standards as applicable.
• Identify and evaluate root cause investigations for equipment and analytical instruments deviations and implement Corrective and Preventative Actions (CAPA) as needed.
• Author, review, approve, and revise Standard Operating Procedures (SOPs) and equipment related protocols such as Installation Qualifications, Operation Qualifications, and Performance Qualifications (IQOQPQ).

How you’ll impact

• Improve and maintain the Validation and Metrology program
• Establish positive relationships across functional departments involved with the use critical equipment and instruments
• Provide professional service oriented support of Terrestrial's Equipment Validation and Metrology Program's objectives.

Who you are

• 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)

Compensation: The anticipated base salary range for this position is $70,000 - $93,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

Onsite expectations: The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.

Location: Woburn, MA and our new, custom facility in Allston MA.

At Terrestrial, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.