Senior Quality Engineering Specialist
Prime Medicine, a leading biotechnology company specializing in gene editing therapies, is seeking a Senior Quality Engineering Specialist to join their Quality Assurance team in Cambridge, MA. This role involves providing hands-on operational support for GxP software, equipment, calibration, preventive maintenance, and vendor oversight activities. The Specialist will collaborate with Quality, Laboratory Operations, IT/Informatics, system and equipment owners, and external vendors to ensure systems and equipment are compliant and inspection-ready.
Key responsibilities include drafting, executing, and reviewing software assurance test scripts, supporting quality oversight of GxP computerized systems, conducting risk-based assessments of software, equipment, material, and service providers, and maintaining equipment, calibration, and preventive maintenance records. The Specialist will also oversee scheduled calibration, maintenance, and service activities, conduct supplier audits and remote assessments, and support change controls, deviations, CAPAs, and other quality records.
Candidates should possess a Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience, along with at least four years of experience in a regulated life-sciences environment. Experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function is required. A working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements is essential. Strong technical writing, organizational, and cross-functional coordination skills are necessary, as is the ability to manage multiple operational priorities and maintain accurate records.
The compensation for this role ranges from $111,000 to $123,000 annually. Prime Medicine offers a comprehensive benefits package, including medical, dental, vision, life insurance, a 401(k) match, equity programs, generous paid time off, wellness days, and company-wide recharge breaks.
Joining Prime Medicine provides an opportunity to be part of a pioneering company at the forefront of gene editing therapies. The organization fosters a collaborative and innovative environment, offering growth opportunities and the chance to contribute to transformative advancements in biotechnology.