Process Development Scientist ID 34225

Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI 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. Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.   

 Responsibilities: 

• Designs, monitors or conducts experimental strategies with general guidance from supervisor.  
• Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function.  
• Monitors field of expertise, including literature and technology development, and communicates relevant observations.  
• May introduce advanced scientific methods.  
• Develops and implements new and novel protocols to address specific issues.  
• May represent the department on project teams under 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. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. 
• Participates in external scientific community.  
• May assume lead role in department-wide support efforts such as safety, recruiting and committees.  
• May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Competencies / Skills: 

• Working knowledge of pharmaceutical/biotech processes. 
• Familiarity with validation and documentation processes in a highly regulated environment. 
• Ability to operate specialized laboratory equipment and computers as appropriate. 
• Ability to interpret and apply GLPs and GMPs. 
• Ability to apply science-based approach to production. 
• Strong Knowledge on Vision system technologies 
• Inspection/packaging Concepts Knowledge 
•  Participation and/or development of Design, installation, and validation of automated processes (URS, SDS, HDS, P&IDs, FS, IQ, OQ, VSR, SOP's)
•  PLC controls programming (Rockwell Automation / Allen Bradley (SLC500, PLC5, Micrologix, Compact Logix and Control Logix), Siemens Simatic/TIA, B&R)
• Vision systems and Vision Tools (Cognex, Systech, Optel, Keyence, EISAI/BOSH/Syntengon, Seidenader, Brevetti, MvTech)
• Industry standards for software development life cycle methodologies, 21 CFR Part 11, and GAMP
• Development and Execution of Processes/Equipment Characterization 
  o Establish Testing Strategies 
  o Design / Development of Characterization Protocols 
  o Technical Reports Development 
  o Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies. 
  o Risk assessments and QRAES knowledge, to support risk assessments activities. 
• 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. 
•  Basic technical report writing and Validation Protocol Writing 
• Technical (Equipment Specific) 
• Basic project management 
• Specialized equipment/process expertise. 

Education: 

• Master degree and 5 years of Scientific experience or bachelor's degree or 6 years of scientific experience.