Manager, Computer System Validation (248)

Civica • Petersburg, VA

12d • Onsite

About The Position

The Manager, Computer System Validation will join the Civica, Inc. (“Civica”) Information Technology organization at the Petersburg, Virginia site, responsible for ensuring that all computer systems and data integrity processes comply with regulatory GMP / GXP requirements and internal standards. This role involves validating on-premises and cloud-based platforms, software, and hardware systems, maintaining data integrity, and supporting audits and inspections. This position collaborates with cross-functional teams to implement and maintain validated GXP systems that support business operations and regulatory compliance.

Requirements

• 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.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager