**At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives.** We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: _“What would I do if this patient were my mom?”_ That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. **Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.** **Position Summary** The GMP Engineering Supervisor is responsible for assisting in company-wide compliance to all applicable regulatory requirements and managing the laboratory’s GMP equipment validation program. This role requires strong communication skills, familiarity with laboratory processes and instrumentation, and leadership skills. **Job Responsibilities** + Maintain compliance to all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDD, etc.) and safety procedures with regards to laboratory instrumentation validation. + Manage and serve as subject matter expert for components of the quality management system (QMS) such as validation lifecycle management systems (VLMS) or other tools. + Collaborate with cross-functional teams to achieve defined business objectives by managing projects, leading meetings, and facilitating partnerships across departments. + Collaborate and assist departments with GMP equipment validations to achieve and maintain regulatory compliance and operational efficiency. + Manage company records in accordance with regulatory requirements and company policies. + Manage a team to maintain oversight of laboratory equipment compliance with regards to the equipment validation lifecycle. + Use problem solving skills to identify, solve problems, or improve processes. + Author, review, revise, and implement standard operating procedures (SOPs) for the QMS. + Participate in internal and external audits. **Required Qualifications** + Bachelor’s degree in biological science, engineering, IT, or similar field. + A minimum of 3 years of experience working within an FDA-regulated laboratory, medical device, or pharma environment. + Demonstrated knowledge of equipment qualification and validations strategies for medical device manufacturing or a related product environment. + Familiar with ISO13485, ISO9001, and FDA regulations/requirements. + Familiar with GAMP5 and GMP principles. + Demonstrated knowledge of equipment maintenance best practices relative to validated systems and processes in a GxP environment. + Previous experience supervising and/or training others on processes. + Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use. **Preferred Qualifications** + Previous experience in a laboratory (next generation sequencing or related field) or quality assurance role is preferred. **Physical Demands** + Employee may be required to lift routine office supplies. + Employee must be able to use standard office equipment. + While the majority of work is performed in a desk/office environment, employee may be required to spend time in the laboratory and may have exposure to high noise levels, fumes, and biohazardous materials. + Employee must have ability to sit for extended periods of time. **Training** + All job specific, safety, and compliance training are assigned based on the job functions associated with this employee. **Other** + This position requires periodic travel and some evenings, weekends and/or holidays. **Conditions of Employment:** Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification. This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation. Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.