Civica Rx · 4 months ago
Manager, Computer System Validation (248)
Petersburg, VA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expCivica Rx is a nonprofit organization focused on addressing critical shortages of essential generic injectable drugs in the U.S. healthcare system. The Manager, Computer System Validation will ensure compliance with regulatory requirements and internal standards for computer systems and data integrity processes, collaborating with cross-functional teams to implement validated systems that support business operations and regulatory compliance.
Pharmaceutical
Responsibilities
Collaborate with Business System Owners, Technical Owners, System Administrators, Engineering, Information Technology, Quality Assurance, and other departments to implement validated GMP / GXP systems
Ensure compliance with GMP / GXP regulatory requirements and frameworks such as U.S. Food and Drug Administration (FDA) 21 CFR Part 11, Annex 11, GAMP 5, and other applicable standards
Develop and execute validation deliverables, policies, and procedures for computer systems and data integrity processes. Computer system validation activities include but are not limited to the following: requirements gathering, validation planning, IQ/OQ/PQ protocol generation, test execution, requirements traceability matrices, system configuration specifications, and validation summary reports
Review and approve system risk and data integrity assessments, and periodic review reports to ensure that GMP / GXP computerized systems remain compliant, secure, and fit for their intended use throughout their lifecycle
Conduct impact assessments for new systems and system changes
Support internal and external audits by providing validation documentation and expertise
Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all computer system validation related matters is provided to the company with a focus on data integrity
Train staff on computer systems validation procedures and data integrity processes / best practices
Qualification
Required
Bachelor's degree in the field of Computer Science, Engineering, Life Sciences, or a related field
8+ years of experience in computer system validation and data integrity in a regulated GMP / GXP environment
Strong knowledge of regulatory requirements and industry standards (e.g., FDA, GAMP, ALCOA++)
Experience with validation tools, documentation, and system development lifecycle management
Excellent leadership, project management, analytical, organizational, and communication skills
Ability to work independently and collaboratively in a team environment
Preferred
10+ years of experience in the pharmaceutical industry, specifically in the computer system validation arena supporting sterile injectable manufacturing
Data Process Flow Mapping techniques used in GMP / GXP data integrity processes to ensure compliance, traceability, and risk mitigation in regulated environments
Experience with Veeva Vaults, Enterprise Resource Planning systems, computerized maintenance management systems, laboratory automation systems, Manufacturing Execution Systems, and manufacturing control systems
Company
Civica Rx
Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.
51-200 employees
H1B Sponsorship
Civica Rx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (2)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$3M2025-08-07Grant· $3M
Leadership Team
Ned McCoy
CEO
Dave Sehgal
Chief Manufacturing and Supply Chain Officer
Recent News
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