Process Development Scientist ID 35470

Posted 2 Days Ago
Be an Early Applicant
Juncos, PRI
In-Office
Mid level
Information Technology
The Role
Designs and executes scientific experiments to support biopharmaceutical formulation and aseptic filling. Performs data analysis, process monitoring, validation protocol execution, deviation investigations, and manufacturing floor support. Prepares regulatory documentation and collaborates 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

Administrative Shift - 8:00AM – 5:00PM

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:

  •  Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
  • 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’s + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience.
      • Preferred: Educational background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).

      Skills Required

      • Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
      • Comprehensive understanding of validation protocol execution requirements and validation processes for new equipment installations.
      • 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, and cross-functional collaboration skills.
      • Education: Doctorate OR Master’s + 2 years scientific experience OR Bachelor’s + 4 years scientific experience.
      • Preferred: Educational background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).
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      The Company
      HQ: San Juan, PR
      19 Employees
      Year Founded: 2004

      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

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