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Computer System Validation Manager Jobs in Boca Raton, FL

System One

System Administrator

Riviera Beach, FL

$22 - $42/hr

Manage multiple projects in a dynamic and demanding environment. Requirements * Valid CompTIA Security + Certificate required. * Experience in maintaining cyber compliant computer systems.

ABBTECH

System Administrator

Riviera Beach, FL · On-site

$35 - $42/hr

System Operations - Maintain continuous, secure operation of cyber compliant computer systems in ... Account & Documentation Management - Set up administrator and service accounts and maintain ...

EōS Fitness

Fitness Manager

Coral Springs, FL · On-site

$60K/yr

Must have valid PT certification. * Previous sales experience required. * Ability to work in a gym ... Ability to access and operate the Company computer system including preparing documents, entering ...

EōS Fitness

Fitness Manager

Boynton Beach, FL · On-site

$60K/yr

Must have valid PT certification. * Previous sales experience required. * Ability to work in a gym ... Ability to access and operate the Company computer system including preparing documents, entering ...

Steve Madden

Store Assistant Manager

West Palm Beach, FL

$16 - $21.50/hr

Process information or merchandise through the computer system and POS register system. * Assist Store Manager in the selection and hiring of qualified candidates. * Be flexible and occasionally ...

Steve Madden

Store Assistant Manager

Pembroke Pines, FL

$15 - $20.25/hr

Process information or merchandise through the computer system and POS register system. Assist Store Manager in the selection and hiring of qualified candidates. Be flexible and occasionally perform ...

EōS Fitness

District Sales Manager

Coral Springs, FL · On-site

$75K - $80K/yr

Must have a valid Driver's License. * Must be able to maintain clean motor vehicle record ... Ability to access and operate the Company computer system including preparing documents, entering ...

Steve Madden

Store Assistant Manager

Sunrise, FL · On-site

$15.50 - $20.75/hr

Process information or merchandise through the computer system and POS register system. Assist Store Manager in the selection and hiring of qualified candidates. Be flexible and occasionally perform ...

Steve Madden

Store Assistant Manager

West Palm Beach, FL · On-site

$16 - $21.50/hr

Process information or merchandise through the computer system and POS register system. * Assist Store Manager in the selection and hiring of qualified candidates. * Be flexible and occasionally ...

Steve Madden

Store Assistant Manager

West Palm Beach, FL

$16 - $21.50/hr

Process information or merchandise through the computer system and POS register system. Assist Store Manager in the selection and hiring of qualified candidates. Be flexible and occasionally perform ...

Steve Madden

Store Assistant Manager

Sunrise, FL

$15.50 - $20.75/hr

Process information or merchandise through the computer system and POS register system. Assist Store Manager in the selection and hiring of qualified candidates. Be flexible and occasionally perform ...

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Computer System Validation Manager information

See Boca Raton, FL salary details

$45.1K

$100K

$152.3K

How much do computer system validation manager jobs pay per year?

As of May 31, 2026, the average yearly pay for computer system validation manager in Boca Raton, FL is $100,035.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,700.00 and $125,300.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What cities near Boca Raton, FL are hiring for Computer System Validation Manager jobs? Cities near Boca Raton, FL with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Boca Raton, FL as of May 2026, with employment types broken down into 46% Full Time, 47% Part Time, and 7% Contract. Highlights an 85% Physical, and 15% Remote job distribution, with an average salary of $100,035 per year, or $48.1 per hour.
Quality Engineer CSV & Digital Systems

Quality Engineer CSV & Digital Systems

Unicon Pharma Inc.

Davie, FL • On-site

$35 - $36/hr

Contractor

Posted 21 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