Validation Lead
About the job
- A Bachelor of Science degree in Science or Engineering is required.
- Conduct periodic reviews of equipment.
- Conduct periodic reviews of controlled temperature chambers.
- Assess computerized systems for enrollment in computerized system periodic review.
- Prepare Annual Product Review reporting for commercial equipment using the systems list.
- Own the Validation Master Plan.
- Own and support deviations and corrective and preventive actions related to validation maintenance issues.
- Assess validation change controls.
- Lead, author, and facilitate Quality Risk Assessments for Equipment and Automated Systems.
- Track performance and report metrics.
- Execute qualification and validation for new or modified equipment.
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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