U.S. Pharmacopeial Convention Jobs

Description

Who is USP?

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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Job Overview

This is a non-supervisory position in the Central Laboratory Operations (CLO) department of USP’s Global Laboratory and Technical Operations (GLTO) division. The incumbent will support and maintain laboratory computer software which will include troubleshooting issues, working with vendors to ensure laboratory IT support when needed, and ensuring laboratory instrument software complies with required ISO standards. The (Associate) Lab Systems Engineer is a critical role in the GLTO division to support USP’s standards development and the USP mission.

How will YOU create impact here at USP?

By supporting our laboratory computer systems, you will enable USP laboratories to adhere to ISO 9001 and 17025 standards. This includes the following responsibilities:

• Troubleshoot hardware, networking and software issues related to laboratory software systems such as Waters Empower, Waters NuGenesis SDMS & LMS (ELN), and other LIMS systems.

• Managing workflow in ServiceNow ticketing system.

• Manage, install, and maintain laboratory software and hardware on validated computer systems.

• Collaborate with QA, IT, facilities, laboratories, and other CLO members to ensure software is maintained in a validated state in compliance with ISO 9001 and 17025 standards through a change control process.

• Build, test and deploy computers with laboratory software; reimage and maintain backups.

• Test and deploy patches prior to implementation.

• Retire and off-board laboratory hardware and software.

• Administer laboratory software packages. Work with vendors to provide on-site support for laboratory software and related equipment.

• Draft and maintain knowledge base articles.

• Respond to internal customer service requests from laboratory end users in a timely manner.

• Other duties as assigned.

Who USP is 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:

• Bachelor’s degree in engineering, physical sciences, or information technology with 4 years relevant laboratory IT experience; OR Master’s degree with 2 years of proven experience; OR 10 years of confirmed experience.

• Familiarity with ISO 9001, ISO 17025, FDA and/or cGXP standards.

• Ability to handle multiple priorities in a fast-paced environment.

• Excellent technical writing and oral communication skills required.

• Able to communicate effectively with diplomacy and enthusiasm with customers across the organization.

• Able to work independently with limited supervision.

• Available to work flexible hours with advance notice.

• Able to lift 50lbs.

Additional Desired Preferences

• Expertise in troubleshooting both hardware and software issues for the following software packages: Waters Empower 3, Waters NuGenesis SDMS, Waters NuGenesis LMS (ELN), Rees Environmental Monitoring, LabX.

• Knowledge of GAMP 5, 21 CFR part 11, ASTM 2500, USP <1058> requirements.

• Experience in software development, validation, qualification and/or testing.

• Advanced excel programming knowledge.

Supervisory Responsibilities

None.

Benefits

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 is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

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

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 Information Technology

Job Type Full-Time