GMP Lab Scientist II — Validation & Analysis

Validation & Engineering Group; Barceloneta (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Scientist II to perform GMP laboratory testing across raw materials, in-process, finished product, stability, and validation.

The role requires strong data interpretation, training of staff, and adherence to procedural requirements in a regulated environment. Responsibilities include data review, method execution, troubleshooting, and implementing process improvements to meet specifications.

Qualifications

• Bachelor's degree in science with 6 years of related experience.
• Master's degree with 4 years of related experience.
• PhD with 2 years of related experience.
• Fully bilingual English/Spanish with excellent oral skills.
• Strong knowledge of cGxP and regulatory guidance.
• Technical writing and investigations experience.

Responsibilities

• Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems.
• Proposes and implements changes to maintain procedural requirements.
• Performs analytical test methods to support product/material release with minimal error.
• Proposes and implements changes to improve laboratory techniques and methodology.
• Can independently troubleshoot analytical techniques and instrument issues.
• Interprets experimental data for conformance with product/material specifications.
• Initiates appropriate exception documents as required.
• Implements improvements to facilitate team objectives.
• Proposes and implements scientific protocols to determine exception event cause.

Skills

Bilingual English/Spanish

Analytical skills

Regulatory compliance

Technical writing

Education

Bachelor's degree in Science (Microbiology/Biology/Chemistry/Bio-Chemistry)

Master's Degree in Science

PhD in Science

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. is seeking a Scientist II to perform GMP laboratory testing across raw materials, in-process, finished product, stability, and validation.

The role requires strong data interpretation, training of staff, and adherence to procedural requirements in a regulated environment. Responsibilities include data review, method execution, troubleshooting, and implementing process improvements to meet specifications.