Validation - CSV Support
About the job
- A bachelor's degree in Engineering or Sciences is required.
- At least 3 years of experience is required.
- 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.
About the company
Validation & Engineering Group provides regulatory compliance and engineering consulting for life sciences clients in Puerto Rico and the USA, serving pharmaceutical, biotechnology, medical device, and food sectors. Its services cover the full product lifecycle, including commissioning and qualification, computer system validation, equipment and process validation, cleaning validation, quality systems, and regulatory compliance aligned with FDA and European standards. The firm pairs practical engineering work with regulatory know-how, delivering assessments, validation activities, documentation, and implementation support to keep facilities and systems compliant. In 2025 it joined Pinnaql Inc. under 3Boomerang Capital, expanding reach and project management while keeping founders as partners to maintain continuity and accelerate client launches.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Guaynabo, Puerto Rico
Founded
1997
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Simplify's Take
What believers are saying
- Pinnaql added Pharma Resource Group on May 20, 2026, broadening advisory depth.
- Pinnaql launched an AI partnership with Valkit.ai on January 7, 2026.
- ZipRecruiter showed Pinnaql hiring in Humacao and Rockville in August 2026.
What critics are saying
- Pinnaql completed three tuck-in acquisitions by April 30, 2026, straining integration.
- ClearCompany listed 185 V&EG jobs on September 12, 2026, signaling operational churn.
- Crowded CQV consultants from local firms and global outsourcers compress pricing and margins.
What makes Validation & Engineering Group unique
- V&EG brings Puerto Rico CQV expertise; Pinnaql acquired it August 6, 2025.
- V&EG covers validation, compliance, and engineering across pharmaceuticals, biotech, devices, and food.
- Founders Ronald Pacheco and Luis Puig stayed on as partners after acquisition.
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