Why this roleThe 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.
