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Biotech Csv Jobs in Florida (NOW HIRING)

TekWissen LLC

Quality Assurance Engineer

Tampa, FL · On-site

$25 - $35/hr

Our client is a leading biotechnology company that combines technological expertise with world ... Exposure to computerized system validation (CSV). * Experience in biologics, pharmaceutical, or ...

Lonza

ERP Head (SAP)

Tampa, FL · On-site

$210 - $320/hr

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

Lonza

ERP Head (SAP)

Tampa, FL · On-site

GxP Compliance & Computer Systems Validation (CSV): Manage the ERP environment in strict compliance ... biotechnology, or healthcare organization. * SAP Delivery Track Record: Proven success leading at ...

Lonza

ERP Head (SAP)

Tampa, FL · On-site

GxP Compliance & Computer Systems Validation (CSV): Manage the ERP environment in strict compliance ... biotechnology, or healthcare organization. * SAP Delivery Track Record: Proven success leading at ...

Actalent

Validation Specialist

Boca Raton, FL

$36.06 - $45.67/hr

... Microbiology, Biotechnology, or related scientific disciplines. * Experience working with sterile manufacturing processes and media fills. * Exposure to Computer System Validation (CSV) in a ...

Lonza

OT Engineer

Tampa, FL · On-site

$90 - $130/hr

Experience working within pharmaceutical, biotechnology, medical device, or other GMP-regulated ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Lonza

OT Engineer

Tampa, FL · On-site

Experience working within pharmaceutical, biotechnology, medical device, or other GMP-regulated ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

Lonza

OT Engineer

Tampa, FL · On-site

Experience working within pharmaceutical, biotechnology, medical device, or other GMP-regulated ... Familiarity with Computer System Validation (CSV), GAMP 5, and 21 CFR Part 11 requirements.

GL Staffing Services, Inc.

Validation

Boca Raton, FL · On-site

$75K - $95K/yr

Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Microbiology, Engineering, or a related ... Computerized System Validation (CSV) -- preferred * Quality Risk Management and risk assessments

All JobsBiotech Csv JobsBiotech Csv Jobs in Florida

Biotech Csv information

What is a Biotech CSV professional?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

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

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.

What are popular job titles related to Biotech Csv jobs in Florida?

For Biotech Csv jobs in Florida, the most frequently searched job titles are:

What job categories do people searching Biotech Csv jobs in Florida look for?

The top searched job categories for Biotech Csv jobs in Florida are:

What cities in Florida are hiring for Biotech Csv jobs?

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Biotech Csv jobs near you

Lead BSA - LMS Transformation & SAP SuccessFactors Migration

Milestone Technologies

Tampa, FL • On-site

$103K - $134K/yr

Contractor

Posted 6 days ago

Job description

Lead BSA - LMS Transformation & SAP SuccessFactors Migration
GxP experience is required
The Lead Business Systems Analyst (Lead BSA) will serve as the primary liaison between business stakeholders and the LMS implementation team, supporting Milestone's enterprise-wide Learning Management System (LMS) transformation program and migration from SumTotal LMS to SAP SuccessFactors Learning.
This role is responsible for leading business analysis activities across all phases of the transformation, including current-state assessments, future-state process design, requirements management, data migration planning, reporting requirements, validation support, user acceptance testing (UAT), and deployment readiness. The Lead BSA will work closely with HR, Legal, Compliance, Quality, Clinical Operations, Regulatory Affairs, IT, system integrators, and executive stakeholders to ensure business needs are accurately translated into scalable and compliant system solutions.
The ideal candidate will possess extensive experience supporting enterprise software implementations within pharmaceutical, biotechnology, medical device, or other GxP-regulated environments and have strong expertise in LMS platforms, process transformation, data migration, and stakeholder management.
Key Responsibilities
  • Lead requirements gathering, business process analysis, and solution design activities supporting the migration from SumTotal LMS to SAP SuccessFactors Learning.
  • Partner with business stakeholders across HR, Quality, Compliance, Regulatory Affairs, and other functions to translate business needs into functional and technical requirements.
  • Facilitate workshops, process reviews, and stakeholder meetings to define future-state learning, compliance, and reporting processes.
  • Document and manage business, functional, technical, and compliance requirements, ensuring traceability throughout the project lifecycle.
  • Analyze current-state LMS processes, workflows, training records, curricula, and reporting structures to identify improvement opportunities.
  • Develop process maps, business capability assessments, use cases, user stories, and supporting solution documentation.
  • Lead business analysis activities related to data migration, including data mapping, cleansing, validation, reconciliation, and training record integrity.
  • Collaborate with technical teams, system integrators, and business owners to resolve data, process, and system issues.
  • Lead User Acceptance Testing (UAT) activities, including test planning, script development, execution support, defect management, and business validation.
  • Support Computer System Validation (CSV), audit readiness, and regulatory compliance activities to ensure solutions meet GxP requirements.
  • Build strong stakeholder relationships and facilitate cross-functional collaboration to drive decision-making and issue resolution.
  • Provide business impact assessments, recommendations, and risk analyses to support governance and project leadership.
  • Define reporting, dashboard, and KPI requirements to support compliance, training effectiveness, adoption, and operational performance.
  • Support organizational change management, deployment readiness, user adoption, and post-implementation stabilization activities.
  • Ensure all business processes, requirements, and system solutions align with regulatory, quality, compliance, and data governance standards.
Required Qualifications
  • Bachelor's degree in Business Administration, Information Systems, Computer Science, Life Sciences, or equivalent work experience.
  • 12+ years of Business Systems Analysis experience supporting enterprise applications and transformation initiatives.
  • 5+ years of experience supporting LMS, HRIS, ERP, or enterprise platform implementations.
  • Demonstrated experience leading requirements and process design activities in complex cross-functional environments.
  • Experience supporting enterprise software implementations and data migration initiatives.
  • Strong understanding of SDLC, Agile, Waterfall, and Hybrid delivery methodologies.
  • Experience working within GxP-regulated environments.
  • Excellent facilitation, communication, documentation, and stakeholder management skills.
  • Ability to work effectively across business, IT, and vendor organizations.

Preferred Qualifications
  • Experience with SAP SuccessFactors Learning implementations.
  • Experience with SumTotal LMS administration or migration projects.
  • Experience supporting Learning Management Systems in pharmaceutical, biotechnology, or medical device organizations.
  • Experience supporting Computer System Validation (CSV) activities.
  • Knowledge of training compliance processes and regulated learning environments.
  • Understanding of organizational change management and process transformation practices.
  • Experience leading business analysis teams or serving as a Lead BSA on large-scale programs.
Tools, Systems & Technical Knowledge
  • SAP SuccessFactors Learning
  • SumTotal LMS
  • Cornerstone OnDemand
  • Workday Learning
  • Other enterprise LMS platforms
  • Jira / Confluence
  • Microsoft Visio / Lucidchart
  • Power BI
  • Tableau
  • Databricks
  • SQL (preferred)
  • Microsoft 365 Suite / Microsoft Teams
  • SharePoint
Preferred Certifications
  • CBAP (Certified Business Analysis Professional)
  • PMI-PBA (Professional in Business Analysis)
  • PMP (Project Management Professional)
  • SAP SuccessFactors Learning Certification
  • Lean Six Sigma Green Belt
  • Agile Certified Practitioner (PMI-ACP)
  • GxP / CSV Certification
The estimated pay range for this position is USD $55.00/Hr - USD $60.00/Hr. Exact compensation and offers of employment are dependent on job-related knowledge, skills, experience, licenses or certifications, and location. We also offer comprehensive benefits. The Talent Acquisition Partner can share more details about compensation or benefits for the role during the interview process.

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