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Director Computer System Validation Csv Jobs in Puerto Rico

Validation & Engineering Group, Inc

PR

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 ...

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 ...

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 ...

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 ...

Mirus Consulting Group

Sr. Engineer

Juncos, PR · On-site

$101K - $139K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States.

JC Automation Corp

PR · On-site

$20/hr

Knowledge of Computer System Validation (CSV) requirements and documentation. * Prior experience ... Highly self-directed -- capable of making sound technical decisions independently during overnight ...

Validation & Engineering Group, Inc

PR

... computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency. • Experience with validation of GxP applications, including Validation ...

Cencora

Sr. Automation Engineer

Juncos, PR

$101K - $132K/yr

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT ... Direct experience working in regulated environments (GMP, OSHA, EPA) * Willingness to travel (30 ...

Validation & Engineering Group, Inc

PR

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

Validation & Engineering Group, Inc

PR

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

Validation & Engineering Group, Inc

PR

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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Computer System Validation (CSV) Specialist (EBR System)

Validation & Engineering Group, Inc

PR

Full-time

Posted 4 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.