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QA Engineer Lead/Manager, EQ Validation and Metrology

Vaxess Technologies · Woburn, MA · On-site

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About Vaxess Technologies

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

About the role

Oversee 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. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • A minimum of BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Physics, or related technical field required
  • Minimum of BS with 6+ / MS with 3+ 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 $100,000 - $140,000 depending on level. 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
More about this role

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 .

The Quality Assurance Engineer Lead/Manager role will manage Terrestrial Bio’s Equipment and Metrology program in support of the testing and manufacture of Terrestrial's combination products, with a strong focus on the calibration, re-certification, preventative maintenance, and qualification for critical equipment and instruments.

Reporting to the Head of Quality and Compliance, this role works...

Read the full posting on Vaxess Technologies's site ↗

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