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Senior Computer System Validation Csv Jobs in Miami, FL

Deloitte

System Test and Validation Lead

Miami, FL · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Miami, FL · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Miami, FL · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Unicon Pharma Inc.

CQV Lead

Davie, FL · On-site

$45 - $50/hr

... System Validation (CSV), data integrity, and 21 CFR Part 11 compliance. 5. Strong understanding of OSD unit operations and equipment (e.g., blending, granulation, compression, coating, encapsulation ...

Hazen and Sawyer

Civil 3D CAD/BIM Designer

Hollywood, FL · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

As part of our team in Florida, you will work alongside staff Engineers and Senior CAD Designers to ... systems * Willingness to be a team player and be proactive to ensure projects stay on time and ...

Hazen and Sawyer

Structural Revit BIM Designer

Hollywood, FL · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Execute redlines from Engineers and senior CAD Designers. * Coordinate structural Revit models and ... Basic understanding of structural steel and concrete systems * Experience with infrastructure ...

Rivian

Regional Manager, Autonomy Systems Validation

Miami, FL · On-site

$114K - $142K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

You will bridge the gap between regional site operations and senior engineering leadership ... system usage/interaction, security and preference information. Rivian may use your Candidate ...

New

Rivian

Regional Manager, Autonomy Systems Validation

Miami, FL

$114K - $142K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

You will bridge the gap between regional site operations and senior engineering leadership ... system; (ii) carrying out, analyzing and improving our application and recruitment process ...

New

Hazen and Sawyer

MEP Revit BIM Designer

Hollywood, FL · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... systems. * Coordinate with other disciplines (Site Civil, Structural, Architectural, HVAC, ... Executing redlines from Engineers and senior CAD/BIM Designers. * Ensure drawing compliance with ...

SUPERMICRO COMPUTER INC

Service Engineer

Miami, FL · On-site

$79K - $87K/yr

... system validation, and root cause analysis Coordinate RMA processes and spare parts logistics ... Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or equivalent ...

Super Micro Computer

Service Engineer

Miami, FL · On-site

$79K - $87K/yr

... system validation, and root cause analysis • Coordinate RMA processes and spare parts logistics ... Computer Science, Computer Engineering, Electrical Engineering, or equivalent work experience ...

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Senior Computer System Validation Csv information

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How much do senior computer system validation csv jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for senior computer system validation csv in Miami, FL is $61.95, according to ZipRecruiter salary data. Most workers in this role earn between $49.42 and $70.34 per hour, depending on experience, location, and employer.

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.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

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 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 most commonly searched types of Computer System Validation Csv jobs in Miami, FL?

The most popular types of Computer System Validation Csv jobs in Miami, FL are:

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For Senior Computer System Validation Csv jobs in Miami, FL, the most frequently searched job titles are:

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Cities near Miami, FL with the most Senior Computer System Validation Csv job openings:

Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in Miami, FL as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $128,858 per year, or $62 per hour.

Quality Engineer CSV & Digital Systems

Unicon Pharma Inc.

Davie, FL • On-site

$35 - $36/hr

Contractor

Re-posted 8 days ago

Job description

Description:

Title: Quality Engineer – CSV & Digital Systems
Shift Details: Monday to Friday 8am – 5 pm (40 hours per week)
Assignment Duration: 6 months with possible extension
Location: Davie, FL

Convert to Perm: Depending on opens and performance

Core Essential skill sets (must have):

  • Recent Master’s graduate Master's degree in Engineering, Computer Science, Life Sciences, or related field.
  • Min 3 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
  • Min 3 years hands-on CSV experience reviewing and approving validation documentation.
  • Direct experience supporting manufacturing or utilities systems (not just lab systems).
  • Medical screening requirements:

Key Responsibilities:

Computer System Validation (CSV)

  • Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports).
  • Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, and Data Integrity (ALCOA+) principles.
  • Evaluate system changes through change control, assessing GxP impact and validation requirements.
  • Support periodic reviews and re-validation activities for existing systems.
  • Digital Systems & Platforms
  • Act as Quality reviewer/approver for systems including:
  • MES / EBR platforms (e.g., Werum PAS-X or similar)
  • Historians (OSIsoft PI or equivalent)
  • Advanced analytics tools (Seeq, used for GxP trending)
  • Empower and other lab systems
  • Review configurations related to data acquisition, time stamping, audit trails, access control, and electronic records/signatures.
  • Ensure proper segregation between GxP vs non-GxP analytics use cases.

Data Integrity & Compliance:

  • Assess and approve data flows, interfaces, and integrations between systems.
  • Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems.
  • Cross-Functional Collaboration
  • Partner with Engineering, Automation, MS&T, IT, and Operations to:
  • Enable faster project execution with compliant validation strategies
  • Avoid over-validation while maintaining inspection readiness
  • Provide Quality input during project design, FAT/SAT, and commissioning phases.

Required Qualifications:

Education:

  • Master's degree in Engineering, Computer Science, Life Sciences, or related field.

Experience:

  • 3-5 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
  • 3+ years hands-on CSV experience reviewing and approving validation documentation.
  • Direct experience supporting manufacturing or utilities systems (not just lab systems).

Required Technical Skills

  • Strong working knowledge of:
  • CSV lifecycle & GAMP 5
  • 21 CFR Part 11 / Annex 11
  • Data Integrity (ALCOA+)
  • Practical experience with:
  • MES / EBR systems
  • Process Historians (PI, etc.)
  • Advanced analytics platforms (Seeq) in a GxP context
  • Ability to evaluate risk-based validation for dashboards, reports, and models.
  • Familiarity with change control, deviations, and CAPA systems.

Preferred / Nice-to-Have

  • Experience with:
  • Werum PAS-X, Seeq, PI Vision, Power BI (for regulated trending)
  • Agile or lean validation approaches
  • Commissioning & Qualification (C&Q) integration with CSV
  • Prior involvement in:
  • FDA inspections related to computerized systems
  • Site digitalization or Industry 4.0 initiatives

Key Competencies

  • Risk-based decision making with quality and compliance focus
  • Strong documentation review and technical writing skills
  • Ability to challenge constructively while remaining solution-oriented
  • Comfortable working at the intersection of Quality, Engineering, and IT
  • Pragmatic mindset: compliant and business-enabling