The Role
Designs and executes process development and validation experiments for sterile drug products. Authors and runs validation protocols, characterization studies, technical reports, investigations, and change controls. Analyzes manufacturing data, advises cross-functional teams, and implements contamination control and aseptic processing solutions. Supports new equipment validation and contributes to technical documentation and project teams.
Summary Generated by Built In
Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift - Able to work different shift and on weekend during characterization or validation
Description:
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
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.
Job Requirements:
- Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
- Validation experience in highly regulated industry. If possible, filling validation and work on technical documentation.
- 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.
- 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.
- Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required.
- Fully bilingual (English/Spanish).
Education:
- Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable
- Master's degree with 3+ years of relevant scientific experience; or bachelor's degree with 5+ years of relevant scientific experience.
- Science background as Engineering or microbiology
Skills Required
- Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
- Validation experience in highly regulated industry and experience with validation documentation.
- Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
- Comprehensive understanding of validation protocol execution requirements and in-depth knowledge of validation processes for new equipment installations.
- Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
- 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.
- Proficiency with Microsoft Office (Excel, Word, and PowerPoint).
- Fully bilingual in English and Spanish.
- Flexible to work different shifts and weekends during characterization or validation activities.
- Education: Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience, or Master's degree with 3+ years relevant experience, or Bachelor's degree with 5+ years relevant experience.
- Science background in Engineering or Microbiology.
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
