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Computer System Validation Csv Pharmaceutical Jobs in Puerto Rico

Validation & Engineering Group, Inc

PR · On-site

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Computer System Validation (CSV) Specialist Project summary: * Validate and support the Electronic ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... computer system validation and information technology consulting services to pharmaceutical ... 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 ... providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

Pharmaceutical Manufacturing Position Type: Contract General The Project Manager will be ... Computer Systems Validation (CSV), or related technologies is preferred. • Strong project ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

Pharmaceutical Manufacturing Position Type: Contract General The Project Manager will be ... Computer Systems Validation (CSV), or related technologies is preferred. • Strong project ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

Pharmaceutical Manufacturing Position Type: Contract General The Project Manager will be ... Computer Systems Validation (CSV), or related technologies is preferred. • Strong project ...

JC Automation Corp

PR · On-site

$20/hr

Familiarity with User Access Management processes and Audit Trail review in a pharmaceutical environment. * Knowledge of Computer System Validation (CSV) requirements and documentation. * Prior ...

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.

Validation & Engineering Group, Inc

PR

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... systems validation (CSV) or computer systems quality assurance, including consulting level ...

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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 some 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, and why are they important?

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.
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Computer System Validation Csv Pharmaceutical jobs near you

Computer System Validation (CSV) Specialist (EBR System)

Validation & Engineering Group, Inc

PR • On-site

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.