Senior Process Scientist

Location: Manati, PR, Puerto Rico
Date Posted: 11-02-2018
SENIOR PROCESS SCIENTIST

Description

Searching for a Sr. Process Scientist with experience in Pharmaceutical Industries.  The candidate must have solid GMP and regulatory experience with expertise in process and equipment validations for manufacturing or packaging process. As Process Scientist, will support includes the processes, formulation and equipment used in the manufacture of parenteral and/ or biological drug products such as sterile filtration, aseptic filling, lyophilization, capping and visual inspection among other key supporting unit operation. 

Responsibilities
  • The Sr.Process Scientist must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices.
  • Designs, evaluates, and executes analytical method validation protocols. Supports technical aspects of test method ruggedness and robustness.
  • Ensure processes are appropriately controlled and executed per process descriptions described in CMC documentation (i.e. QEs, discrepancies and support to complaint investigations), Process Optimization (i.e. DOE ‘s), and other technical protocols to support the process (which may include Aseptic Processing Validation (Media Fills), Process Validation, Experimental protocols) and other Technology Transfer activities. 
  • Writes strong technical documents related to Manufacturing and Quality Support 
  • Hands on in the development, improvement and validation of analytical methods. Writes comprehensive technical reports to document the analytical work executed.
 
Requirements
  • Bachelor Degree in Science, Chemistry or Chemical/ Mechanical Engineering or any other related Science field and 5 years of experience.
  • 3 years of experience in pharmaceutical technology transfer and process improvements.
  • Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry
  • Parenteral/filling line process experience
  • Knowledge on statistical analysis software tools
  • Fully bilingual
 
Ultimate Solutions Corp is an Equal Opportunity Employer.
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