The Role
Designs and executes experiments to support process development and validation for protein formulation and filling. Analyzes data, develops protocols, supports investigations and root-cause analysis, provides manufacturing floor support, and prepares regulatory documentation while collaborating cross-functionally.
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.
Non Standard Shift
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 in inspection (manual/automatic), packaging area, incoming (primary containers).
- Experience in Process Development Lab
- Understanding of protein science, formulation and filling processes.
- Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP)
- Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
- Ability to provide manufacturing floor support in a fast-paced, 24/7 operation.
- Bilingual proficiency in Spanish and English (written and verbal).
- Strong technical writing skills with experience preparing documentation for regulatory audits.
- Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills.
Education:
- Doctorate OR Master + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience.
Skills Required
- Experience in inspection (manual and automatic) and packaging area (incoming primary containers).
- Experience in a Process Development laboratory.
- Understanding of protein science, formulation, and filling processes.
- Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP).
- Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
- Ability to provide manufacturing floor support in a fast-paced, 24/7 operation (non-standard shifts).
- Comprehensive understanding of validation protocol execution requirements and validation processes for new equipment installations.
- Bilingual proficiency in Spanish and English (written and verbal).
- Strong technical writing skills with experience preparing documentation for regulatory audits.
- Excellent communication, presentation, problem-solving, project management, and cross-functional collaboration skills.
- Education: Doctorate OR Master + 2 years scientific experience OR Bachelors + 4 years scientific experience.
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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
