Scientist II

Validation & Engineering Group; Barceloneta (PR); Sur place; USD 75 000 - 110 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Bilingual English/Spanish

Analytical skills

Regulatory compliance

Technical writing

Formation

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

Master's Degree in Science

PhD in Science

Outils

MS Windows

Microsoft Office

Description du poste

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.
Excited to build something meaningful together? We look forward to hearing from you.
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.