Scientist II

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

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

Requires science degree with multi-year experience and bilingual English/Spanish; strong analytical skills; MS Windows/Microsoft Office proficiency; and solid knowledge of cGxP regulatory guidance. Extended hours may be required.

Qualifications

• Bachelor’s degree in Science (Microbiology, Biology, Chemistry or Bio-Chemistry) with 6 years of related field experience.
• Master’s degree in Science (same fields) with 4 years of related field experience.
• PhD in Science (same fields) with 2 years of related field experience.
• Fully bilingual English/Spanish with excellent oral skills.
• Strong analytical skills and logical thought process.
• Proficient with cGxP and regulatory guidance for compliance.

Responsibilities

• Maintains GMP-compliant laboratory records, procedures and systems.
• Proposes changes to maintain procedural requirements and improve techniques.
• Performs analytical test methods to support product/material release with minimal error.
• Troubleshoots and resolves analytical instrument issues.
• Interprets experimental data for conformance with specifications.
• Initiates appropriate exception documents as required.
• Implements improvement ideas to support team objectives.

Skills

Bilingual English/Spanish

Analytical skills

MS Windows & MS Office

Technical Writing

Regulatory compliance (cGxP)

Extended hours availability

Education

Bachelor’s degree in Science

Master’s degree in Science

PhD in Science

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Scientist II

Description

Performs laboratory testing within a GMP environment in support of one or more of the following areas; raw materials, in-process product, finished product, stability, and/or validation. Uses scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. Interprets data output to determine conformance with product specifications. Reviews and verifies data generated by others to determine conformance with product specifications. Understands internal business process, to make appropriate prioritization of their assigned work duties. Has experience and command of multiple laboratory techniques to perform them with minimal error. Can train other laboratory personnel on any technique they currently have in their training matrix.

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.

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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.