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Computer System Validation Csv Pharmaceutical Jobs in Florida

Actalent

Validation Specialist

Boca Raton, FL

$36.06 - $45.67/hr

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

New

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

OT Engineer

Tampa, FL · On-site

Ensure OT systems remain reliable, secure, and compliant within a regulated pharmaceutical ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Lonza

OT Engineer

Tampa, FL · On-site

Ensure OT systems remain reliable, secure, and compliant within a regulated pharmaceutical ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Lonza

OT Engineer

Tampa, FL · On-site

Ensure OT systems remain reliable, secure, and compliant within a regulated pharmaceutical ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Lonza

ERP Head (SAP)

Tampa, FL · On-site

$210 - $320/hr

GxP Compliance & Computer Systems Validation (CSV) GxP Compliance & Computer Systems Validation ... pharmaceutical, biotechnology, or healthcare organization. SAP Delivery Track Record: Proven ...

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

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 ...

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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All JobsComputer System Validation Csv Pharmaceutical JobsComputer System Validation Csv Pharmaceutical Jobs in Florida

Computer System Validation Csv Pharmaceutical information

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

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

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.
What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Florida? For Computer System Validation Csv Pharmaceutical jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Florida look for? The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Florida are:
What cities in Florida are hiring for Computer System Validation Csv Pharmaceutical jobs? Cities in Florida with the most Computer System Validation Csv Pharmaceutical job openings:
Computer System Validation Csv Pharmaceutical jobs near you

Quality Engineer CSV & Digital Systems

Unicon Pharma Inc.

Davie, FL • On-site

$35 - $36/hr

Contractor

Re-posted 3 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