Laboratory Informatics Engineer
Rockville, MD
| Employer: | US Pharmacopeia |
| Category: | Information Technology |
| Job Type: | Full Time |
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Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities 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 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. 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—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, 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. Brief Job Overview This is a hands-on subject matter expert role in the Central Laboratory Operations (CLO) department within the Global Laboratory and Technical Operations (GLTO) division. The role is responsible for creating and maintaining laboratory software in an operational and validated state as per ISO 17025 requirements. This includes developing, installing, validating (CSV), and ensuring the continued operation of excel based spreadsheets, electronic notebook forms, chromatographic custom fields, and other laboratory software. How will YOU create impact here at USP? In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments. The position's purpose should provide a high-level overview of why the position exists and briefly identify the most critical priorities of the position. This is an opportunity to highlight any features or duties of the role related explicitly to the Diversity, Equity, Inclusion & Belonging work of the Department. The Lab Informatics Engineer has the following responsibilities: • [20 %] Create and deploy computerized forms, custom fields, spreadsheets, and reports. • [20 %] Respond to internal customer troubleshooting requests for software issues related to laboratory software systems and ensure prompt closure of open tickets. • [20 %] Plan, schedule, draft, execute, review, and approve software validation protocols, either in-house or through vendors. This includes creating, revising, and validating spreadsheets, custom fields, and forms used for laboratory calculations. • [20 %] Collaborate with QA, IT, facilities, laboratories, and other CLO staff to ensure software is maintained in a validated state and compliant with ISO 9001 and 17025 requirements. This involves updating procedures and processes, and documenting deviations and CAPAs. • [20 %] Test, validate, and document updates, patches, upgrades, and changes made to laboratory software. Who is USP 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 six (6) years of relevant laboratory informatics experience; or a master’s degree with four (4) years of relevant laboratory informatics experience; or 10 years of relevant laboratory informatics experience. • Strong understanding of ISO 9001, ISO 17025, and/or cGXP quality programs. Additional Desired Preferences • Computer systems validation (CSV) experience, including Excel-based forms utilizing Visual Basic. • In-depth laboratory computer software troubleshooting skills. • Experience with Waters Empower, Waters NuGenesis Lab Management System (LMS), Waters NuGenesis SDMS, Rees Environmental Monitoring, and LabX software. • Deep knowledge and understanding of GAMP 5, 21 CFR part 11, ASTM 2500, USP , ISO 9001, and ISO 17025 requirements. • Applied knowledge of SQL databases and Python programming. • Demonstrates flexibility in work hours to meet operational needs. While adhering to standard business hours of 8:30 a.m. to 5:00 p.m., Monday through Friday, actively contributes to a team providing 24/7 emergency alarm response. Readily available on short notice to accommodate requests during non-standard hours, including early mornings or late evenings on weekdays, ensuring dependable support in critical situations. Supervisory Responsibilities None. 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. Compensation Base Salary Range: USD $85,500.00 – $111,250.00 annually. Target Annual Bonus: 10% Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons. 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 | |