QA Equipment Lead — Metrology & Calibration (Hybrid)

Terrestrial Bio; Walnut Hill (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

Terrestrial Bio in Massachusetts is seeking a Quality Assurance Engineer Lead/Manager to oversee the Equipment and Metrology program. You will calibrate and maintain critical instruments, ensure cGMP/compliance, and drive CAPA with Manufacturing, Process Development and Quality teams.

The role reports to the Head of Quality and Compliance, requiring a BS or MS in a technical field and 6+ years (BS) or 3+ years (MS) in regulated manufacturing. Onsite 4–5 days/week in MA.

Qualifications

• BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Physics, or related technical field.
• MS in a related field (preferred).
• Minimum of BS with 6+ years or MS with 3+ years in a regulated manufacturing environment (Pharma, Biotech, or Medical Device).
• Strong mechanical skills and good grasp of analytical instrumentation, measurement systems, and manufacturing equipment.
• Working knowledge of cGMP requirements and ISO/IEC17025.

Responsibilities

• Oversee calibration schedules and procedures for equipment used in manufacture, testing, and storage of cGMP products.
• Lead root cause investigations for equipment deviations and implement CAPA as needed.
• Author, review, approve, and revise SOPs and equipment-related protocols (IQ/OQ/PQ).
• Act as SME on calibration and preventive maintenance of equipment/instruments with cross-functional teams to ensure cGMP compliance.
• Collaborate with Facilities, Manufacturing and Quality Control to ensure proper equipment qualification and operation.

Skills

Calibration experience

CAPA implementation

SOP authoring

cGMP knowledge

Analytical instrumentation

Education

BS in Mechanical/Electrical/Chemical Engineering or Physics

MS in a related field

Job description

Terrestrial Bio in Massachusetts is seeking a Quality Assurance Engineer Lead/Manager to oversee the Equipment and Metrology program. You will calibrate and maintain critical instruments, ensure cGMP/compliance, and drive CAPA with Manufacturing, Process Development and Quality teams.

The role reports to the Head of Quality and Compliance, requiring a BS or MS in a technical field and 6+ years (BS) or 3+ years (MS) in regulated manufacturing. Onsite 4–5 days/week in MA.