Sr Process Validation Scientist

Location: north, PR, Puerto Rico
Date Posted: 11-29-2017
Searching for a 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. Provide technical support to the day to day manufacturing operations for products manufactured at the Manatí Parenteral Manufacturing Facility. 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. 

  • The 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.
  • Bachelor Degree in Science, Chemical Engineering, Biology, Pharmacy or Microbiology
  • Equipment Validation/Qualification experience or Cleaning Validation for Parenteral products
  • Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry
  • Buffer and Formulation characterization and parenteral Tech Transfer
  • Three (3) years in Process Validation
  • Five (5) years of experience as Scientist in a 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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