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Fda Scientist Jobs in Puerto Rico (NOW HIRING)

JC Automation Corp

PR · On-site

Ensure strict adherence to cGMP regulations, FDA guidelines, and internal site procedures. Support ... D. in Life Sciences, Chemical Engineering, Pharmacy, Bioengineering, or a closely related ...

Biosimilar Sciences PR LLC

PR · On-site

Understanding of FDA cGMP regulations, ICH guidelines, and industry best practices related to tech transfer and manufacturing sciences. Skills * Strong analytical and problem-solving skills. * Strong ...

Mentor Technical Group

Deviations Owner

Juncos, PR · On-site

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

Biosimilar Sciences PR LLC

PR · On-site

Deep understanding of ICH, FDA, EMA, and global regulatory guidelines relevant to analytical sciences. * Excellent leadership, communication, and stakeholder management skills. * Ability and ...

Mentor Technical Group

Network Engineer

Salinas, PR · On-site

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

Mentor Technical Group

Porfolio Manager

Gurabo, PR · On-site

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

Maintain compliance with cGMP, FDA, EMA, ICH, and company quality standards. * Support internal ... Bachelor's Degree in Engineering, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Life ...

Biosimilar Sciences PR LLC

PR · On-site

We are committed to compliance with FDA, EMA, and ICH requirements and to fostering a strong ... scientific discipline (Master's degree preferred). · Minimum 5 years of experience in ...

MMR Consulting

PR · On-site

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline. * Strong understanding of: * cGMP regulations * FDA validation requirements * ISPE Baseline ...

MMR Consulting

PR

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline. * Strong understanding of: * cGMP regulations * FDA validation requirements * ISPE Baseline ...

MMR Consulting

PR · On-site

Bachelors degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline. * Strong understanding of: * cGMP regulations * FDA validation requirements * ISPE Baseline ...

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All JobsFda Scientist JobsFda Scientist Jobs in Puerto Rico

Fda Scientist information

What is an FDA Scientist job?

An FDA Scientist is a researcher or regulatory expert responsible for evaluating the safety, efficacy, and quality of pharmaceutical drugs, medical devices, biologics, and food products. They conduct laboratory research, review clinical trial data, and assess regulatory submissions to ensure compliance with federal laws and guidelines. FDA Scientists play a critical role in protecting public health by making science-based decisions on product approvals and safety standards.

What types of projects and responsibilities can I expect as an FDA Scientist?

As an FDA Scientist, you'll typically be involved in reviewing data from clinical trials, conducting laboratory research, evaluating the safety and efficacy of pharmaceuticals or medical devices, and preparing reports for regulatory submissions. You'll collaborate closely with multidisciplinary teams including chemists, statisticians, and regulatory specialists to ensure scientific rigor and adherence to federal standards. Some days may involve detailed data analysis, while others could require participating in cross-team meetings or interacting with external stakeholders. This dynamic environment offers opportunities to contribute to important public health decisions and develop specialized expertise over time.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, as well as senior scientific and medical directors. These positions often require advanced degrees, extensive experience, and leadership skills, and they can earn salaries exceeding $200,000 annually, with additional benefits and bonuses.

How much do FDA scientists make?

FDA scientists typically earn between $70,000 and $130,000 annually, depending on experience, education, and location. Entry-level positions often start around $70,000, while experienced scientists or those with advanced degrees can earn higher salaries, especially with specialized skills or supervisory roles.

Is it hard to get hired by the FDA?

Getting hired as an FDA scientist can be competitive due to the specialized qualifications required, such as relevant degrees and experience in regulatory science or related fields. Candidates often need to pass rigorous screening processes, including interviews and background checks, and may require certifications or knowledge of FDA regulations. Strong technical skills and familiarity with the agency's procedures improve hiring prospects.

What are the key skills and qualifications needed to thrive in the Fda Scientist position, and why are they important?

To thrive as an FDA Scientist, you need a solid background in biology, chemistry, pharmacology, or a related scientific field, typically supported by at least a bachelor's or advanced degree. Familiarity with regulatory submission systems, laboratory information management systems (LIMS), and relevant certifications such as Good Laboratory Practice (GLP) or Good Clinical Practice (GCP) is important. Strong analytical thinking, attention to detail, and effective communication skills help you excel when collaborating with colleagues and presenting findings. These abilities ensure accurate data review and regulatory compliance, which are crucial for advancing public health and safety.

Does the FDA employ scientists?

Yes, the FDA employs scientists in various roles such as biologists, chemists, and pharmacologists to evaluate the safety and effectiveness of medical products, foods, and cosmetics. These scientists often work in laboratories, conduct research, and analyze data to support regulatory decisions, typically requiring relevant degrees and certifications. Their work is essential to ensuring public health and safety standards are met.
What are popular job titles related to Fda Scientist jobs in Puerto Rico? For Fda Scientist jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Fda Scientist jobs in Puerto Rico look for? The top searched job categories for Fda Scientist jobs in Puerto Rico are:
Fda Scientist jobs near you
Infographic showing various Fda Scientist job openings in Puerto Rico as of July 2026, with employment types broken down into 80% Full Time, 17% Part Time, 2% Contract, and 1% Nights. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.
Principal Process Scientist

Principal Process Scientist

JC Automation Corp

PR • On-site

Full-time

Posted 9 days ago

Job description

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

We are seeking a Principal Process Scientist to serve as the Subject Matter Expert (SME) for sterile manufacturing processes, with specialized focus on liquid and lyophilized parenteral products. This senior-level role combines deep scientific expertise with hands-on operational support, driving process optimization, compliance, and technology transfer in a cGMP pharmaceutical environment.

The ideal candidate brings extensive experience in manufacturing operations, complex investigations, process validation, and cross-functional leadership, ensuring strategic alignment with site priorities and regulatory requirements.


RESPONSIBILITIES

  • Subject Matter Expertise (SME): Serve as the primary technical authority for sterile manufacturing processes, including liquid and lyophilized parenteral products, providing guidance to manufacturing, engineering, quality, and validation teams.
  • Daily Manufacturing Support: Support daily manufacturing operations with advanced technical expertise, ensuring processes operate within validated parameters and in compliance with cGMP and site procedures.
  • Troubleshooting & Process Optimization: Lead technical troubleshooting efforts for manufacturing deviations and process-related issues. Drive continuous process optimization to improve yield, efficiency, and product quality.
  • Investigations & CAPA Management: Lead and manage complex investigations, including root cause analysis for deviations. Develop and implement effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.
  • Process Validation: Plan and execute process validation activities, ensuring all protocols, reports, and supporting documentation meet regulatory and internal standards.
  • Technology Transfer: Lead technology transfer efforts for new or existing products, coordinating with cross-functional teams to ensure successful scale-up and site integration.
  • Regulatory Compliance: Ensure strict adherence to cGMP regulations, FDA guidelines, and internal site procedures. Support regulatory inspections and audits as the technical SME for sterile manufacturing processes.


REQUIREMENTS & QUALIFICATIONS

Required

  • Bachelor's, Master's, or Ph.D. in Life Sciences, Chemical Engineering, Pharmacy, Bioengineering, or a closely related scientific discipline.
  • Extensive background in sterile manufacturing processes with specialized focus on liquid and lyophilized parenteral products.
  • Proven experience supporting daily manufacturing operations and providing advanced technical troubleshooting.
  • Demonstrated capability in managing complex investigations, root cause analysis, and CAPA implementation.
  • Hands-on experience executing process validation activities and leading technology transfer efforts.
  • Deep understanding of cGMP regulations, FDA guidelines, and compliance requirements in a highly regulated pharmaceutical environment.
  • Exceptional cross-functional collaboration skills with manufacturing, engineering, quality, and validation teams.


Preferred

  • Ph.D. or advanced degree with focus on sterile pharmaceutical manufacturing or bioprocessing.
  • Experience supporting FDA or EMA regulatory inspections as a process SME.
  • Familiarity with lyophilization process development and scale-up.
  • Experience with statistical tools for process monitoring and data analysis (e.g., JMP, Minitab).


SKILLS

Technical Skills

  • Sterile manufacturing processes — liquid and lyophilized parenteral products
  • Process validation (IQ/OQ/PQ/PPQ) and technology transfer
  • Deviation management, root cause analysis, and CAPA systems
  • cGMP regulations, FDA guidelines, and regulatory documentation
  • Continuous process improvement and optimization methodologies
  • Technical writing — protocols, reports, SOPs, and investigation summaries
  • Microsoft Office 365


Soft Skills

  • Senior-level technical leadership and SME authority
  • Strong cross-functional collaboration and stakeholder alignment
  • Analytical mindset with structured problem-solving capabilities
  • Ability to manage multiple priorities in a fast-paced regulated environment
  • Clear scientific communication across technical and non-technical audiences
  • Adaptability and availability to support other shifts as business needs require