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Manager, Computerized Systems (512)

Employer
Civica Rx
Location
Petersburg, VA
Start date
Jan 26, 2025
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Job Details

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Job Description

The Computerized System Manager for Laboratory IT oversees the implementation, validation, and maintenance of the computerized systems supporting GxP Laboratory Operations. You will be responsible for ensuring the laboratory systems' compliance, quality, and efficiency and maintaining data throughout the data lifecycle.

Essential Duties and Responsibilities:

  • Manage existing LIMS and CDS systems and drive the selection, installation, testing, maintenance, training, and support of additional laboratory systems. 
  • Ensure the laboratory systems and data comply with the regulatory requirements, industry standards, and best practices for data integrity, security, and quality. 
  • Implement and monitor data integrity controls, such as user access, audit trails, backups, electronic signatures, data review, and data transfer, to ensure the laboratory data's accuracy, completeness, consistency, and availability. 
  • Manage the integration, validation, and maintenance of stand-alone lab instruments and ensure their compatibility and connectivity with laboratory systems and data. 
  • Perform system administration tasks for Empower, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc. 
  • Troubleshoot and resolve any issues related to Empower, such as network, database, instrument, or software problems.
  • Coordinate with vendor and ensure the proper configuration, upgrade, backup, and recovery of the Empower system. 
  • Collaborate with cross-functional stakeholders to understand the laboratory needs and deliver computerized system solutions that enable analytical excellence and data integrity controls.
  • Manage the computerized system budget for Laboratory Systems, resources, and vendors, ensuring the optimal utilization and allocation of the system assets and services. 
  • Cross-train to provide backup support for other Site IT needs.
  • Monitor and report on the computerized system performance, risks, and issues, and implement corrective and preventive actions as needed. 
  • Identify and drive computerized system innovation and improvement opportunities, leveraging new technologies and methodologies.

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • A bachelor’s degree in computer science, engineering, or a related field with 8+ years of experience in computerized system roles in the pharmaceutical or biotechnology industry. 
  • A strong knowledge of the computerized system principles, standards, and regulations, such as GAMP 5, 21 CFR Part 11, EU Annex 11, etc. 
  • A solid understanding of laboratory processes, systems, and technologies, including LIMS and CDS. 
  • A familiarity with the stand-alone lab instruments, their functions, and their requirements, such as calibration, qualification, and data transfer.
  • Experience implementing data integrity controls.
  • Proficiency in the Empower system, its features, and its administration, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc. 
  • Experience in troubleshooting and resolving issues related to Empower, such as network, database, instrument, or software problems. 
  • Capable of working independently against deadlines in a fast-paced, and dynamic environment. 
  • High level of analytical, problem-solving, and decision-making skills.
  • Excellent communication, collaboration, and leadership skills.

Preferred Qualifications:

  • Experience with MODA LIMS preferred.
  • Advanced experience in project management and change management.
  • Strong knowledge of computerized system validation
  • Experience with ELN and implementation of paperless lab. 

Position ID: 512

Shift: Day Shift. Monday through Friday.

Company

WHY CIVICA?
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone. 
 
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile. With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs available by 2023.   

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Company info
Website
Location
1 Civica Way
Petersburg
VA
23805
United States

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