Associate Validation Engineer

USP • Rockville, MD

5d • $33 - $42

About The Position

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 USP’s mission and strategic objectives, while supporting internal stakeholders and laboratory operations.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related fiel5d, with a minimum of one (1) year 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.

Nice To Haves

• 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, and LabX.
• Knowledge of other regulatory and quality standards, such as GAMP 5, 21 CFR Part 11, USP <1058>.

Responsibilities

• Work closely with laboratory staff in executing validation, metrology, and calibration activities.
• Support equipment and instrumentation calibration, verification, maintenance, and qualification.
• 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 USP’s 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level