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Senior Computer System Validation Csv Jobs in Florida

Axogen

Sr. Dynamics 365 Technical Architect

Tampa, FL

Job Summary of the Sr. Dynamics 365 Technical Architect The Sr. Dynamics 365 Technical Architect ... Ensure adherence to Computer System Validation (CSV) requirements within a Life Sciences * Maintain ...

Inteldot

Senior SAP EWM Business Analyst

Jacksonville, FL · On-site

$85K - $110K/yr

Position Summary We are seeking an experienced Senior SAP EWM Business Analyst to support ... Ensure compliance with GxP, SOX, Computer System Validation (CSV), and FDA 21 CFR Part 11 ...

TekWissen LLC

Quality Assurance Engineer

Tampa, FL · On-site

$25 - $35/hr

Perform additional duties as assigned by the Senior Manager of QA Operations. Required ... Exposure to computerized system validation (CSV). * Experience in biologics, pharmaceutical, or ...

Inteldot

Senior SAP EWM Business Analyst

Jacksonville, FL · On-site

$48.50 - $64.75/hr

Position Summary We are seeking an experienced Senior SAP EWM Business Analyst to support ... Ensure compliance with GxP, SOX, Computer System Validation (CSV), and FDA 21 CFR Part 11 ...

Inteldot

Senior SAP EWM Business Analyst

Jacksonville, FL · On-site

$48.50 - $64.75/hr

Position Summary We are seeking an experienced Senior SAP EWM Business Analyst to support ... Ensure compliance with GxP, SOX, Computer System Validation (CSV), and FDA 21 CFR Part 11 ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

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Senior Computer System Validation Csv information

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges Senior Computer System Validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a Senior Computer System Validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
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Senior Computer System Validation Csv jobs near you

Sr. Software Quality Engineer (Computer Software Validation-CSV)

MDAEdge

Jacksonville, FL • On-site

Full-time

Posted yesterday

Job description

Job Summary:
MDAEdge is a company focused on software quality in the medical device sector, and they are seeking a Senior Software Quality Engineer to lead Computer Software Validation (CSV) projects. The role involves managing software validation documentation, supporting compliance efforts, and promoting cross-functional collaboration within the organization.
Responsibilities:
• Lead Computer Software Validation (CSV) project planning activities, including the creation and updates of User Requirements Specifications (URS), Software Design Specifications (SDS), and Requirements Traceability Matrices (RTM).
• Develop, review, and approve software validation documentation.
• Create and execute qualification protocols, document reports, and review and approve software test scripts and code reviews.
• Evaluate and approve internal and vendor software packages and test documentation.
• Prioritize and manage all assigned projects within the software validation department.
• Implement and support policies, procedures, and processes related to CSV, Software Development Life Cycle (SDLC), and software validation for computerized systems.
• Serve as the Software Quality Engineering (SQE) representative in the Change Control Board (CCB) to facilitate change validation.
• Lead Installation Qualification (IQ) activities for manufacturing lines.
• Drive CSV improvement initiatives within the manufacturing environment.
• Promote cross-functional collaboration across different teams, sites, and operating companies in the area of CSV.
• Identify and resolve obstacles that impact business needs.
• Work closely with Franchise Quality to implement and sustain Quality System initiatives at the site level.
• Support compliance efforts by ensuring audit readiness and participating in internal and external audits related to CSV.
• Act as the Subject Matter Expert (SME) for CSV, leading investigations, responses, and remediation of site-specific CSV audit findings.
Qualifications:
Required:
• Strong working knowledge of FDA and European medical device regulations (QSR and ISO).
• Expertise in software validation requirements for both medical device production and Quality System software.
• Proficiency in GAMP5 and SDLC methodologies.
• In-depth understanding of regulations for electronic records, electronic signatures, and data integrity.
• Experience in change management with strong technical writing skills.
• Hands-on experience with SCADA and/or Manufacturing Execution Systems (MES), with a background in manufacturing/operations.
• Minimum of 4 years of experience in a regulated environment.
• 2-4 years of experience in medical device regulations.
• Strong knowledge of FDA and European medical device regulations (QSR and ISO).
• Expertise in software validation for medical device production and Quality System applications.
• Working knowledge of GAMP5 and SDLC.
• Understanding of electronic records, electronic signatures, and data integrity regulations.
• Experience with change management and technical writing.
• Hands-on experience with SCADA and/or MES in a manufacturing/operations setting.
Preferred:
• Medical device process validation experience.
• Experience in Quality Auditing and notified body inspections.
• Background in Quality Systems process development, support, integration, or enhancement.
• Experience in training or coaching others.
• Certification as a Software Quality Engineer (CSQE) or Quality Engineer (CQE).
Company:
The world doesn't have a talent shortage. It has a talent alignment problem. MDA Edge exists to fix that. Founded in , the company is headquartered in Sheridan, WY, US, , with a team of 51-200 employees. The company is currently Growth Stage.

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