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Director Computer System Validation Csv Jobs in Florida

Actalent

Validation Specialist

Boca Raton, FL

$36.06 - $45.67/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Exposure to Computer System Validation (CSV) in a pharmaceutical or cGMP environment. * Familiarity with cleaning validation principles and practices. * Experience collaborating with cross-functional ...

TekWissen LLC

Quality Assurance Engineer

Tampa, FL · On-site

$25 - $35/hr

... computer systems, validation, and laboratory instruments. * Contribute to continuous improvement ... Exposure to computerized system validation (CSV). * Experience in biologics, pharmaceutical, or ...

Lonza

ERP Head (SAP)

Tampa, FL · On-site

$210 - $320/hr

  • Retirement

  • PTO

GxP Compliance & Computer Systems Validation (CSV) GxP Compliance & Computer Systems Validation ... Build and scale the SAP internal capability team (5-10 direct, 20-40 indirect reports); lead ...

Deloitte

System Test and Validation Lead

Lake Mary, FL · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Tampa, FL · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Tampa, FL · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Miami, FL · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Lake Mary, FL · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Tampa, FL · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Lake Mary, FL · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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Quality Engineer CSV & Digital Systems

Unicon Pharma Inc.

Davie, FL • On-site

$35 - $36/hr

Contractor

Re-posted 7 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