Validation Engineer

Company: United States Pharmacopeia
Location: Rockville
Posted on: February 22, 2026

Job Description:

Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. Brief Job Overview This is a hands-on, non-supervisory role within the Central Laboratory Operations (CLO) department of the Global Laboratory and Technical Operations (GLTO) division. The incumbent will execute and support routine validation activities, ensuring compliance with USP standards, regulatory requirements, and industry best practices. In addition, this role provides technical support to metrology operations, assisting in instrument calibration, qualification, and measurement system management. The position contributes to the continuous improvement of the validation program, aligning with USPs mission and strategic objectives, while supporting internal stakeholders and laboratory operations. How will YOU create impact here at USP? As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USPs People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The Validation Engineer has the following responsibilities: Plan, oversee, and support the qualification of analytical laboratory equipment through a combination of CLO-led testing and vendor-executed activities including but not limited to: HPLC/UPLC systems, GC systems, UVVis spectrophotometers, FTIR, balances, KF titrators, dissolution equipment, temperaturecontrolled units (freezers, incubators, stability chambers), and other automated or computerized laboratory instruments Oversee calibration and preventive maintenance programs, review calibration certificates, evaluate OOT results, and ensure timely corrective actions. Work closely with laboratory staff in executing validation, metrology, and calibration activities. Maintain accurate, up-to-date logbooks, equipment records, and documentation in compliance with SOPs and regulatory requirements. Perform necessary administrative functions such as filing paperwork, photocopying, and reviewing laboratory and department data. Coordinate with vendors on scheduling and provide support during on-site visits, ensuring smooth and compliant execution of validation and calibration activities. Demonstrate the ability to perform testing, troubleshooting, and technical work independently while following established protocols. Assist in the development, implementation, and continuous improvement of laboratory validation and measurement system programs. Ensure compliance with safety procedures, quality standards, and regulatory requirements in all laboratory activities. Stay current with best practices, industry trends, and regulatory changes relevant to validation and metrology activities. Perform other duties as assigned, supporting USPs mission and operational excellence. Foundational understanding of regulatory requirements, accreditation standards, and ISO guidelines, and the ability to apply this knowledge to validation planning, documentation, and execution. Strong interpersonal skills with the ability to collaborate effectively across cross-functional teams. Comfortable communicating technical concepts to both technical and non-technical stakeholders. Demonstrated adaptability in a fast-paced environment with shifting priorities. Proactive problem-solver with strong critical-thinking skills and sound judgment. Highly organized with strong attention to detail and consistent follow-through. Ability to manage multiple tasks simultaneously while maintaining accuracy and compliance. Self-motivated, with a strong sense of ownership and accountability in daily work. Who is USP Looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: Bachelors degree in engineering, Life Sciences, or a related field, with a minimum of two (2) years of relevant validation experience. Knowledge of quality management systems, including ISO 9001, ISO 17025, and/or current Good Laboratory/Manufacturing Practices (GLP/GMP). Familiarity with validation processes for laboratory instruments and software, including IQ/OQ/PQ. Strong analytical and problem-solving skills, with the ability to document and communicate findings clearly. Ability to work effectively with cross-functional teams and support compliance with regulatory requirements. Ability to work effectively with diverse colleagues and customers in a cooperative and professional manner. Additional Desired Preferences Basic troubleshooting skills hands-on experience with laboratory systems. Familiarity with SQT qualification testing on Agilent and Waters Empower systems is a plus. Exposure to laboratory software systems, such as Waters Empower, Waters NuGenesis Lab Management System (LMS), Waters NuGenesis SDMS, Rees Environmental Monitoring, andLabX. Knowledge of other regulatory and quality standards, such as GAMP 5, 21 CFR Part 11, USP . Supervisory Responsibilities None, this is an individual contributor role Benefits USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. Compensation Base Salary Range: USD $73,400 - $.93,300 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidates skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor. Job Category Laboratory/Production Job Type Full-Time

Keywords: United States Pharmacopeia, Dale City , Validation Engineer, Science, Research & Development , Rockville, Virginia