BioSpace
Manager, Computer System Validation (248)
BioSpace, Virginia State University, Virginia, us, 23806
Manager, Computer System Validation (248)
The Manager, Computer System Validation role will join the Civica Information Technology organization at the Petersburg, Virginia site, and is responsible for ensuring that all computer systems and data integrity processes comply with regulatory GMP / GXP requirements and internal standards. This position involves validating on-premises and cloud-based platforms, software, and hardware systems, maintaining data integrity, and supporting audits and inspections. It collaborates with cross-functional teams to implement and maintain validated GXP systems that support business operations and regulatory compliance. 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 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. Validation activities include 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 provide expert advice and appropriate technical support on all computer system validation matters with a focus on data integrity. Train staff on computer system validation procedures and data integrity processes / best practices. Minimum Qualifications (Knowledge, Skills, And Abilities)
Bachelor’s degree in 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 Qualifications
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 (MES), and manufacturing control systems. Physical Demands And Work Environment
While performing the essential duties of this position, the employee is regularly required to speak or hear, and to use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee may occasionally lift and/or move up to 25 pounds. Specific vision abilities include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Seniority level
Mid-Senior level Employment type
Full-time Job function
Information Technology Industries
Internet News
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The Manager, Computer System Validation role will join the Civica Information Technology organization at the Petersburg, Virginia site, and is responsible for ensuring that all computer systems and data integrity processes comply with regulatory GMP / GXP requirements and internal standards. This position involves validating on-premises and cloud-based platforms, software, and hardware systems, maintaining data integrity, and supporting audits and inspections. It collaborates with cross-functional teams to implement and maintain validated GXP systems that support business operations and regulatory compliance. 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 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. Validation activities include 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 provide expert advice and appropriate technical support on all computer system validation matters with a focus on data integrity. Train staff on computer system validation procedures and data integrity processes / best practices. Minimum Qualifications (Knowledge, Skills, And Abilities)
Bachelor’s degree in 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 Qualifications
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 (MES), and manufacturing control systems. Physical Demands And Work Environment
While performing the essential duties of this position, the employee is regularly required to speak or hear, and to use hands or fingers to handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee may occasionally lift and/or move up to 25 pounds. Specific vision abilities include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Seniority level
Mid-Senior level Employment type
Full-time Job function
Information Technology Industries
Internet News
#J-18808-Ljbffr