Systems Consultant/Engineering Manager jobs in Petersburg, VA

AboutCivica

Civicais a 501(c)(4) social welfare organization established in 2018 by healthsystems and philanthropies to reduce chronic generic drug shortages and relatedhigh prices in the United States. Civica is led by an experienced team ofhealthcare and pharmaceutical industry leaders. 

Today,more than 55 health systems have joined Civica. They represent over 1,500hospitals and one-third of all U.S. hospital beds. Civica has also begun tosupply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defenseand the U.S. Strategic National Stockpile of essential medicines. 

Civicarecently announced plans to expand its mission, via a unit called CivicaScript,to into the outpatient pharmacy space and to manufacture and distributeinsulins that, once approved, will be available to people with diabetes atsignificantly lower prices than insulins currently on the market. Theavailability of Civica’s affordable insulins, beginning in 2024, will benefitpeople with diabetes who have been forced to choose between life sustainingmedicines and living expenses, particularly those uninsured or underinsured whooften pay the most out of pocket for their medications.

Civica’smission is to ensure that quality generic medications are accessible andaffordable to everyone. Since established, the #1 Policy for the Civica teamhas been “Do What Is in the Best Interest of Patients.” Civica’smanufacturing facility in Petersburg, Virginia, is the future home ofaffordable insulin and essential sterile injectable medicines. The facility iscurrently in late-stage construction and hiring for the site is well-underway.

To findout more about how Civica’s innovative model is directly impacting patientcare, click here to read a summary from the NewEngland Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learnmore about Civica’s plans to bring affordable insulin to Americans living withdiabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

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.