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Csv Validation Engineer Jobs in Florida (NOW HIRING)

TekWissen LLC

Quality Assurance Engineer

Tampa, FL · On-site

$25 - $35/hr

Quality Assurance Engineer Location: Tampa, FL - 33634 Duration: 12 months Job Type: Temporary ... Exposure to computerized system validation (CSV). * Experience in biologics, pharmaceutical, or ...

Lonza

OT Engineer

Tampa, FL · On-site

OT Engineer Tampa, FL Today, Lonza is a global leader in life sciences operating across five ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Lonza

OT Engineer

Tampa, FL · On-site

OT Engineer Tampa, FL Today, Lonza is a global leader in life sciences operating across five ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Lonza

OT Engineer

Tampa, FL · On-site

OT Engineer Tampa, FL Today, Lonza is a global leader in life sciences operating across five ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Unicon Pharma Inc.

CQV Lead

Davie, FL · On-site

$45 - $50/hr

... Validation (CSV), data integrity, and 21 CFR Part 11 compliance. 5. Strong understanding of OSD ... This role is intended for engineers who own qualification outcomes end-to-end--from interpreting ...

Strive Pharmacy

GMP Systems Administrator

Alachua, FL · On-site +1

... 5 CSV principles and the data integrity standards that govern a regulated pharmaceutical environment. The administrator partners directly with Quality, Engineering, Validation and Operations ...

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Csv Validation Engineer information

What are the key skills and qualifications needed to thrive as a CSV validation engineer, and why are they important?

To thrive as a CSV (Computer System Validation) Validation Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, documentation systems, and quality management software is typically required, along with knowledge of industry standards like GAMP 5. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support safe, compliant operations in regulated environments.

What is a CSV validation engineer?

CSV Validation Engineers are professionals responsible for ensuring that computerized systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulations. CSV stands for Computer System Validation, which involves testing and documenting that systems function as intended and meet regulatory requirements for data integrity and security. These engineers typically create validation protocols, perform risk assessments, and support audits. Their work is crucial to ensure that electronic records and processes are reliable, traceable, and meet legal and industry guidelines.

What are some common challenges faced by a CSV validation engineer when working with cross-functional teams?

As a CSV Validation Engineer, one common challenge is ensuring clear communication and understanding between IT, QA, and business process teams regarding regulatory requirements and validation protocols. Misalignment on validation deliverables or timelines can occur, especially when teams have differing priorities or levels of familiarity with compliance frameworks. Proactively facilitating discussions, clarifying documentation, and providing training on Computer System Validation standards can help bridge gaps and keep projects on track.

What is the difference between Csv Validation Engineer vs Data Quality Analyst?

AspectCsv Validation EngineerData Quality Analyst
Required CredentialsBachelor's in Computer Science, Data Management, or related field; familiarity with data validation toolsBachelor's in Data Science, Statistics, or related; certifications like CDMP are common
Work EnvironmentData teams, software development, quality assuranceData analysis, reporting, data governance teams
Industry UsageTech, finance, healthcare, where data validation is criticalBusiness intelligence, analytics, data management sectors

The Csv Validation Engineer primarily focuses on validating and ensuring the accuracy of CSV data files through automated tools and scripts. In contrast, the Data Quality Analyst evaluates overall data quality, identifies issues, and implements data governance practices. Both roles require strong analytical skills and familiarity with data management, but their core responsibilities differ in scope and focus.

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Csv Validation Engineer jobs near you
Infographic showing various Csv Validation Engineer job openings in Florida as of August 2026, with employment types broken down into 40% Full Time, and 60% Contract. Highlights an 100% In-person job distribution.

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

MDAEdge

Jacksonville, FL • On-site

Full-time

Re-posted 14 days ago

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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