Bilingual GMP Lab Scientist II – Validation & Testing

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

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks a Scientist II to perform GMP-lab testing across raw materials, in-process, finished product, and stability studies, ensuring data conformance with specifications.

You will interpret data, train other personnel, and help maintain compliant records while supporting method validation and continuous improvement in a fast-paced environment. Candidates should hold a science degree with relevant experience, be bilingual in English and Spanish,

Qualifications

• Bachelor's degree in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 6 years of experience in related field.
• Master's Degree in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 4 years of experience in related field.
• PhD in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 2 years of experience in related field.
• Manages multiple priorities and comply with deadlines.
• Maintains their certifications as needed for assigned job tasks.
• Demonstrates strong analytical skills and logical thought process.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Proposes and implements changes to maintain procedural requirements.
• Performs analytical test methods as written to support product/material release with minimal error.
• Proposes and implements changes to improve laboratory techniques and methodology.
• Can independently troubleshoot and resolve analytical techniques and instrument issues.
• Interprets experimental data for conformance with product/material specifications.
• Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles.
• Initiates appropriate exception documents in accordance with procedural requirements.
• Implements and ensures improvement ideas are completed to facilitate team objectives.
• Proposes and implements scientific protocols to determine exception event cause.

Skills

Bilingual English/Spanish

Analytical skills

Microsoft Windows proficiency

Microsoft Office

Education

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

Master's degree in Science (Microbiology/Biology/Chemistry)

PhD in Science (Microbiology/Biology/Chemistry)

Tools

Microsoft Office

Microsoft Windows

Job description

Validation & Engineering Group, Inc. in Puerto Rico seeks a Scientist II to perform GMP-lab testing across raw materials, in-process, finished product, and stability studies, ensuring data conformance with specifications.

You will interpret data, train other personnel, and help maintain compliant records while supporting method validation and continuous improvement in a fast-paced environment. Candidates should hold a science degree with relevant experience, be bilingual in English and Spanish,