Validation & Engineering Group

Life sciences validation and compliance consulting

Validation - CSV Support

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours

Full-timeGuaynabo, Puerto RicoNo salary listedIn-person

About the Job

Requirements

A bachelor's degree in Engineering or Sciences is required.
At least 3 years of experience is required.

Responsibilities

Provide support for the Computer System Validation lifecycle.
Develop Software Development Life Cycle (SDLC) documents for manufacturing equipment, including Computer System Validation executions and reports.
Prepare validation deliverables as required by the client, which may include User Requirements Specifications (URS), Functional Risk Assessments (FRA), Design Qualification (DQ), preliminary Failure Mode and Effects Analysis (pFMEA), risk assessments, traceability matrices, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation and Operational Qualification (IOPQ), media fills, cleaning validation, and process validation.
Develop a Computer System Validation system impact and risk assessment as part of the combined equipment and Computer System Validation plan.
Develop Installation and Operational Qualification protocols and summary reports.
Review and include Computer System Validation test scripts in Installation and Operational Qualification.

Job Description

Provide support for the CSV lifecycle

This position will work with Computer System Validation (CSV), IQ, OQ, GAMP5 CSV and will be responsible for:

Develop SDLC documents for Manufacturing Equipment including CSV executions and reports
Validation protects as required by client.
The validation deliverables may include URS, FRA, DQ, pFMEA, Risk Assessments, Traceability Matrix, FAT, SAT, IOPQ, Media Fill, Cleaning Validation, Process Validation.
Development of CSV System Impact and Risk Assessment as part of the requirements of combined Equipment and CSV Validation Plan.
Development of IOQ protocol and Summary Report
Review and Tests script inclusion (CSV) to Installation and Operational Qualification.

Qualifications

BS Engineering, Sciences

3+ years of experience

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

About the Company

Validation & Engineering Group

Life sciences validation and compliance consulting

Validation & Engineering Group provides regulatory compliance and engineering consulting for life sciences clients in Puerto Rico and the USA, serving pharma, biotechnology, medical devices, and food sectors. It guides the full product lifecycle, performing commissioning and qualification, computer system, equipment, process, and cleaning validation, drafting quality systems, and ensuring regulatory compliance with FDA and European standards. The firm differentiates itself with hands-on engineering expertise combined with deep regulatory knowledge and broad geographic reach, now enhanced after joining Pinnaql Inc. through an acquisition by 3Boomerang Capital, with founders continuing as partners for continuity. Its goal is to help clients bring products to market faster and more reliably by sustaining GMP-compliant operations and ongoing lifecycle compliance.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Guaynabo, Puerto Rico
Founded: 1997

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