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US Pharmacopeia · 1 day ago

Associate Validation Engineer

Rockville, MD

Contract

Onsite

Entry Level

$32.97/hr - $41.85/hr

1+ years exp

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization dedicated to developing quality standards for medicines and dietary supplements. The Associate Validation Engineer will execute and support routine validation activities, ensuring compliance with USP standards and regulatory requirements while providing technical support to metrology operations.

MedicalNon ProfitPharmaceuticalPublishing

H1B Sponsor Likely

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

Qualification

Validation experienceISO 9001ISO 17025Laboratory PracticesAnalytical skillsLaboratory software systemsProblem-solving skillsInterpersonal skillsAdaptabilityAttention to detailSelf-motivated

Required

Bachelor's degree in Engineering, Life Sciences, or a related field, 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