Quality Engineer/ Scientist
About the job
- A bachelor's degree in sciences or engineering and 3 to 5 years of directly related experience are required.
- Project management skills are required.
- Strong organizational skills are required.
- Strong knowledge in the area of expertise is required.
- Ability to collaborate and coordinate with higher-level outside resources is required.
- Strong knowledge of and experience with processes involved in manufacturing and distribution are required.
- Experience with validation and process development is required.
- Ability to interact with regulatory agencies is required.
- Strong word processing, presentation, database, and spreadsheet application skills are required.
- Strong written and oral communication, facilitation, and presentation skills are required.
- Ability to evaluate compliance issues is required.
- Availability to work requested non-standard shifts is required.
- Full bilingual proficiency in Spanish and English is required.
- Support the Quality Assurance program, including non-conformances.
- Review and approve product MPs.
- Approve validation protocols and reports for manufacturing processes.
- Approve Environmental Characterization reports.
- Lead investigations.
- Review risk assessments.
- Support automation activities.
- Support facilities and environmental programs.
- Approve investigations and CAPA records.
- Approve change controls.
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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