Quality Engineer

Position Type: Full-Time Location: Alachua, FL (Onsite Monday - Friday) 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 facilities, systems, software, and equipment, meeting all partner needs in compliance with standard operating procedures. Specific activities 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; 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 and 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. Collaborate 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 and may require exerting up to 10 pounds of force to move objects. Requires visual acuity for working with data, figures, computer monitor, extensive reading and general observations of facilities. Participation in an occupational health program, including medical assessment, surveillance, vaccination, and testing. Use of personal protective equipment such as respirators, personal air purifying respirators (PAPR), gowns, gloves, face protection, and other barrier equipment. Exposure: Use of personal protective equipment including respirators, PAPR, gowns, gloves, face protection, other barrier equipment. Handling, managing, and disposing hazardous and non‑hazardous waste (chemicals, universal and e‑waste, oil, aqueous wastewater) with potential exposure to bloodborne pathogens. Working in laboratories, production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled. The items described here are representative of those that must be met to successfully perform the essential functions of this job. 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: Professional Engineer (PE) or Engineer-in-Training (EIT) preferred. Salary:

$100,000 - $110,000 USD

Benefits: Comprehensive benefits package including employer‑paid healthcare coverage after 30 days of employment, choice of FSA/HSA, parental leave, 401(k) plan with matching contributions. Employees receive free compounded medications for themselves and immediate family members. Equal Employment Opportunity: Strive Pharmacy is an equal‑opportunity employer that is committed to diversity and inclusion. 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. #J-18808-Ljbffr Strive Pharmacy