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Senior Computer System Validation Csv Jobs in Puerto Rico

Validation & Engineering Group, Inc

PR · On-site

Computer System Validation (CSV) Specialist Project summary: * Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company ...

Techengpr

CSV C&Q Technical Lead

Carolina, PR · On-site

$120 - $180/hr

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $117K/yr

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality systems, procedures, and applicable regulations. * Collaborate with cross-functional teams to ...

JC Automation Corp

PR · On-site

$25 - $35/hr

Exposure to Computer System Validation (CSV) activities and documentation. * Familiarity with OSI PI historian or equivalent data contextualization platforms. * Prior experience in a pharmaceutical ...

Validation & Engineering Group, Inc

PR

Alert senior management of quality, compliance, supply, and safety risks. * Provide support and ... Experience in computer systems validation (CSV) or computer systems quality assurance, including ...

JC Automation Corp

PR · On-site

Support execution of the Computer System Validation (CSV) lifecycle, including requirements, specifications, testing, and qualification. * Support Performance Qualification (PQ) of equipment and ...

Cencora

Sr. Automation Engineer

Juncos, PR

$101K - $132K/yr

  • Medical

  • Dental

  • Vision

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...

CIS International LLC

PR

Provide technical leadership for commissioning, qualification, and computer system validation activities, including: * Leading and executing end-to-end qualification and lifecycle management of ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Projects may support one or more of the following areas: manufacturing systems, process equipment ...

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Senior Computer System Validation Csv information

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 Puerto Rico?

The most popular types of Computer System Validation Csv jobs in Puerto Rico are:

What job categories do people searching Senior Computer System Validation Csv jobs in Puerto Rico look for?

The top searched job categories for Senior Computer System Validation Csv jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Senior Computer System Validation Csv jobs?

Cities in Puerto Rico with the most Senior Computer System Validation Csv job openings:

Senior Computer System Validation Csv jobs near you

Computer System Validation (CSV) Specialist (EBR System)

Validation & Engineering Group, Inc

PR • On-site

Full-time

Posted 25 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

  • Computer System Validation (CSV) Specialist

Project summary:

  • Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements.

Scope of work:

  • Develop/execute CSV deliverables for EVRS modules that manage recipes (formulas), master batch records, and batch execution.
  • Confirm system requirements, risk assessment, and traceability for recipe data, electronic signatures, audit trails, and change control.
  • Perform vendor/system assessments, GAP analysis, and mapping to regulatory controls.
  • Create/execute validation artifacts: URS, VRA, FRS/SRS (if applicable), DQ/IQ/OQ/PQ (or equivalent), test scripts, test execution results, traceability matrix, validation summary report.
  • Support configuration, data migration/verification of recipe records, user acceptance testing, and remediation/defect closure.
  • Provide CSV support during go-live and initial production batches, and handover to QA/IT for periodic review.

Deliverables:

  • Validation project plan and schedule
  • Requirements traceability matrix (RTM)
  • Risk assessment (e.g., FMEA/Hazard analysis for recipes)
  • Design qualification (DQ) report
  • Installation qualification (IQ) procedures & reports
  • Operational qualification (OQ) procedures & reports (including negative/edge cases for recipe execution)
  • Performance qualification (PQ) scripts & reports (including sample batch runs)
  • Test scripts and executed test evidence, incl. electronic signature and audit trail verification
  • Data migration plan and verification evidence for recipe/master records
  • Validation summary report and final sign-off package
  • SOP/Work instruction reviews and CSV-related training materials
  • Post-implementation validation support

Resource profile / qualifications:

  • CSV specialist with 5+ years experience validating EBR/EVRS systems in regulated pharma/biotech/medical devices.
  • Experience with 21 CFR Part 11, EU Annex 11, GMP, and applicable GCP/GLP as needed.
  • Hands-on experience writing/executing IQ/OQ/PQ and creating traceability matrices.
  • Experience with recipe management, MES/SCADA/ERP integrations, and data migration for master recipes.

Preferred:

  • Computer science/engineering or life-science degree; certification(s) such as ASQ, ISPE, or vendor-specific EVRS experience.
  • Available to work additional hours and weeks-ends if required at certain time
  • First shift project
  • On site project

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.