The U.S. Pharmacopeial Convention (USP) (Senior) Validation Engineer in Rockville, Maryland
This is a hands-on non-supervisory role in the Central Laboratory Operations (CLO) department within the Global Laboratory and Technical Operations (GLTO) division. The incumbent is responsible for executing routine validation activities at USP and assisting in implementing improvements to the validation program to meet USP’s objectives and the needs of internal customers to support USP’s mission and continued growth.
Roles and Responsibilities
Ensure all laboratory equipment is properly installed, qualified, maintained, and calibrated according to ISO 9001 and 17025 standards.
Manage schedules and execute in-house qualification, calibration, preventative maintenance, and other validation and metrology activities to ensure instruments remain in compliance with ISO standards and SOPs. Instrumentation includes, but is not limited to, U/HPLC, GC, pipettors, water systems, hydrogen generators, KF titrators, analytical balances, etc.
Draft protocols and SOPs for the qualification of equipment.
Diagnose issues, make repairs, and maintain records for equipment and instruments.
Train laboratory personnel and team members on applicable policies and procedures on equipment and instrumentation.
Perform other duties as assigned.
BS degree and 4 years (Senior Validation Engineer) of relevant experience in validation OR
BS and 2 years (Validation Engineer) of relevant experience in validation.
Prior experience in a pharmaceutical, biotech or a scientific based industry.
Two years of experience with installation, performance maintenance, troubleshooting, and support end-user utilization of scientific instrumentation.
Previous Waters/ Agilent product suite experience (GC, LC, LC/MS, HPLC/UPLC).
Ability to perform effective system-level troubleshooting.
Experience in analytical or QC laboratories utilizing Empower 3 Enterprise and NuGenesis LMS is strongly preferred.
Knowledge in developing validation protocols and execution of protocols.
Demonstrated understanding of FDA regulations, GMP's, and GLP's.
Waters SystemQT (SQT) knowledge is a plus.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. 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
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Laboratory/Production
Job Type Full-Time