Senior Process Development Scientist - Sterile Validation

Inteldot; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot, a life science partner with over 15 years of experience, seeks an Administrative Scientist in Puerto Rico to independently conceive, design, and advance scientific experiments, leading projects and ensuring robust data under GMP guidelines.

The role emphasizes aseptic filling operations, validation protocols, and collaboration with Manufacturing, Quality, Regulatory, and Technical Services to support commercial readiness and continuous process improvement.

Qualifications

• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Validation experience in highly regulated industry.
• Experience in filling validation and work on technical documentation.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.
• Experience with technical data analysis and scientific documentation.

Responsibilities

• Designs, monitors, or conducts strategies with general guidance from the supervisor.
• Provides data analysis and interpretation and assesses the impact of the data on the project. Keeps current in technical expertise and areas relevant to their function.
• Monitors field of expertise, including literature and technology development, and communicates relevant observations.
• Develop and implement new and novel protocols to address specific issues.
• May represent the department on project teams under the supervision of a senior scientific staff member.
• May initiate productive collaborations within and outside of the department or company.
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
• Able to develop solutions to routine technical problems of limited scope.
• Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.

Skills

Statistical analysis

Cross-functional collaboration

Technical writing

Project management

Data analysis

Problem solving

Education

PhD/MD/PharmD

Master's degree in relevant field

Bachelor's degree in Science/Engineering

Engineering or microbiology background preferred

Tools

JMP

Minitab

Job description

Inteldot, a life science partner with over 15 years of experience, seeks an Administrative Scientist in Puerto Rico to independently conceive, design, and advance scientific experiments, leading projects and ensuring robust data under GMP guidelines.

The role emphasizes aseptic filling operations, validation protocols, and collaboration with Manufacturing, Quality, Regulatory, and Technical Services to support commercial readiness and continuous process improvement.