Validation Scientist II (960-679)
This is a non-supervisory position responsible for supporting all domestic laboratory operations. The incumbent is recognized as a technical expert regarding analytical instrumentation and systems. The incumbent in this role will interact with both USP and vendor service personnel to ensure that service activities are completed on time in order to meet USP’s objectives. The incumbent will be involved in the development of operating procedures and qualification protocols, and will execute internal protocols.
Roles and Responsibilities:
- Coordinates on-site service events with USP-approved vendors, in conjunction with equipment availability to minimize impact to the laboratory. This requires that the incumbent be the primary contact for on-site management of vendor staff during the service visit period.
- Forecasting of future service events to communicate upcoming events to laboratory and vendors so that operations can be maintained without impact.
- Develops calibration, verification and/or qualification protocols for operations that can be performed internally, and executes approved protocols to document the operational state of equipment.
- Create and/or revise Standard Operating Procedures (SOPs) to support Validation and Laboratory activities.
- Reports deviations and nonconformities according to USP practices and supports the investigation process to document any impacts.
- Develops understanding of compliance software applications for operations including asset management, document control, and CAPA processes.
- Provide training and guidance to CLO and laboratory staff members.
- Continuously search for and recommend areas of improvement in operations and procedures, and follow through to see improvements are made.
- Bachelor’s degree in Chemical Engineering, physical sciences, or relevant field.
- Minimum of four (4) years of hands-on experience in the validation and/or qualification of analytical laboratory instrumentation and equipment.
- Minimum of four (4) years of experience working within ISO 9001, ISO 17025, or cGMP quality programs.
- Minimum of three (3) years of experience in analytical instrumentation service/support role.
- Prior experience in a scientific based industry, preferably Pharmaceutical/Biotech.
- Experience with GC instrumentation operation, troubleshooting and service/repair
- Experienced in foreseeing potential issues, investigating outcomes, and negotiating successful resolutions.
- The ability to influence decisions without direct authority.
- Results driven with demonstrated successful outcomes.
- Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
- Ability to handle multiple priorities in a fast-paced environment.
- Excellent written and verbal communications skills.
- Able to work independently with limited supervision.
- Able to work flexible hours on occasion with advance notice.
USP offers an impressive benefits package, including:
- Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
- An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
- Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods 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.Job Location Rockville, Maryland, United States Position Type Full-Time/Regular