Quality Engineer

Company Overview Strive Pharmacy is a personalized compounding pharmacy built on a simple conviction: medicine should fit the patient, not the other way around. We started Strive because we believed the pharmaceutical industry was overdue for a more human approach—one that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers. Compounding gives us the tools to do that. Every formulation we prepare is built to the specific needs of a specific person, and every interaction we have is guided by that same commitment to personalized care. We're growing, and we're looking for people who share that conviction. If you're ready to be part of a pharmacy that takes the work seriously and the people even more seriously, we'd like to meet you. Mission Strive exists to disrupt an industry long overdue for a more personal approach to care. We put the human element at the center of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're a team on a mission to change what personalized healthcare looks and feels like. Position Type Full-Time Location Alachua, FL (Onsite Monday - Friday) Salary $100,000 - $110,000 Reporting To Director of Quality Position Overview The Quality Engineer will partner and collaborate with the QA and Engineering teams to ensure that all required qualifications and validations are performed for the facilities, systems, software and equipment, meeting all partner needs in compliance with standard operating procedures. Specific activities will include review of study design, protocols, execution and reports associated with equipment and process validation studies. Provide review and approval of laboratory method validation and verification. This role will provide technical reviews for Quality risk Assessments, investigations and process evaluations for compounding and laboratory equipment as applicable. Key Responsibilities Ensure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality procedures. Develop, review, and approve validation documentation including Validation plans, Protocols (IQ, OQ, PQ), reports and summary documents. Support lifecycle management of validated systems and software, including requalification, change control, and periodic review. Provide guidance on risk-based validation strategies aligned with industry standards (e.g., GAMP, ICH Q9). Provide quality engineering support to analytical laboratories. Assist with equipment validation/verification and troubleshooting activities. Support laboratory equipment qualification and lifecycle management. Lead or participate in cross-functional quality improvement projects. Drive initiatives related to process optimization, validation efficiency, and quality system improvements. Support implementation of new technologies, automation, or process changes requiring validation oversight. Provide technical expertise during new product introduction (NPI) or process transfer activities. Provide day-to-day quality engineering support to operations. Support deviation investigations, CAPA development, and root cause analysis. Participate in change control assessments, ensuring proper validation impact evaluation. Review and approve technical documentation related to manufacturing and quality systems. Collaborates with engineering and manufacturing functions to ensure quality standards are in place and maintained. Role/Site Specific Requirements This role is primarily a Sedentary role. This can include exerting up to 10 pounds of force to move objects. Visual acuity such as: working with data & figures, viewing computer monitor, extensive reading, operating machinery, general observations of facilities, etc. Participation in an occupational health program which can include medical assessment, surveillance, vaccination, and testing. Use of personal protective equipment which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc. Exposure To The Following Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc. Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens. Working in laboratories & production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled. Qualifications Bachelor’s degree in Engineering (Chemical, Electrical or Mechanical) preferred. Minimum of 5 years of experience in facilities, equipment, utilities and FDA regulated environment. Bonus Qualifications PE or EIT, preferred. Work Environment This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities. Join Us In Making An Impact At Strive, the work is real and the impact is direct. Every role here contributes to a patient experience that's more personal, more attentive, and more human than what most people have come to expect from a pharmacy. Apply today and help us raise the bar. Benefits / Perks Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date. Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider. Paid time off. Sick time. FSA and HSA options. Parental leave. 401(k) with employer matching. Life insurance. Vision and dental insurance. Veterinary insurance. Culture Culture isn't an afterthought at Strive. It's something we actively build. At our Gilbert, Arizona location, that looks like Food Truck Fridays and Casual Fridays. Company-wide, we also celebrate throughout the year with holiday potlucks and seasonal gatherings. We're committed to supporting the personal and professional growth of every employee, inside and outside the workplace. EEO Statement Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws. Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you. #J-18808-Ljbffr Strive Compounding Pharmacy