QA Engineer Lead/Manager, EQ Validation and Metrology

Terrestrial Bio • Woburn, MA

42d • $100,000 - $140,000 • Onsite

About The Position

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 cross-functionally with Manufacturing, Process Development, Quality Control, and Facilities by scheduling and/or performing the calibration and preventative maintenance of critical equipment and instruments to ensure critical equipment/instrumentation is operating within expected operating parameters to include qualification for intended use.

Requirements

• 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)

Nice To Haves

• Improve, Develop and Manage the Metrology program which may include the management of personnel with the QA Equipment Validation and Metrology Program
• Establish positive relationships across all departments as an advocate for stakeholders to accomplish their agendas.
• Provide professional service oriented support in support of Terrestrial Bio’s Quality Assurance objectives.

Responsibilities

• 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.
• Lead 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, Operating Qualifications, and Performance Qualifications (IQOQPQ).
• Act as the subject matter expert (SME) on the calibration and preventative maintenance of all equipment/instruments partnering with Facilities, Manufacturing and Quality Control to ensure cGMP compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager