Scientist II

Pinnaql; Barceloneta (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Pinnaql seeks a Scientist II to perform GMP-lab testing in support of raw materials, processes, finished products, stability, and validation. You will interpret data, ensure conformance with specs, and train others on techniques within the training matrix.

The role requires strong analytical skills, instrument qualification experience, and ability to manage multiple priorities. This is a challenging, mission-driven position in a regulatory-driven environment.

Qualifications

• Bachelor's degree in Science with 6 years of related field experience.
• Master's Degree in Science with 4 years of related field experience.
• PhD in Science with 2 years of related field experience.
• Proven experience managing multiple priorities and meeting deadlines.
• Maintains required certifications for assigned tasks.
• Demonstrates strong analytical and logical thinking.
• Experience with instrument qualification and data integrity risk assessments.
• Experience in software qualification and change controls.

Responsibilities

• Understands, implements, and maintains GMP for laboratory records, procedures, and systems.
• Proposes and implements changes to maintain procedural requirements.
• Performs analytical test methods as written to support product material release.
• Proposes and implements improvements to laboratory techniques and methodologies.
• Independently troubleshoots analytical techniques and instrument issues.
• Interprets data to confirm conformance with product specifications.
• Reviews data generated by others for conformance with specs.
• Initiates exception documents as per procedures.
• Drives improvement ideas to support team objectives.

Skills

Bilingual EN/ES

Strong analytical skills

MS Windows

Microsoft Office

Education

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

Master's Degree in Science (same fields)

PhD in Science (same fields)

Tools

MS Windows

Microsoft Office

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

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.
• Extensive experience and expertise in instrument and equipment qualification.
• Proven experience in software qualification.
• Demonstrated ability to manage change controls as the owner and conduct comprehensive impact assessments.
• Experience conducting data integrity risk assessments.
• Strong project leadership, communication, and results-driven execution skills.
• Experience in software qualification.
• 4 years in equipment qualification – Required.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

At Pinnaql, 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.

Pinnaql 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.