Validation Engineer III

ID# DCCA31550


dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

Job Description: 

  • The current project phase entails assessment of existing WIP Tanks, Product Transfer Lines, Tote Transfer Stations, and High Volume Filling Systems for CIP operation utilizing a new fully automated CIP Stationary System. 
  • Cleaning developments will be completed to assess the most effective cleaning process. 
  • Will be led by a technical lead and will be part of a team performing cleaning cycle developments and cleaning validations.
  • Independent and team-based troubleshooting and investigations of any issues affecting the cleaning developments and cleaning validations will be expected for automated system and process issues, including correlation between sensor feedback and parameter setpoints, expected system behavior versus actual behavior, and resolution for proper control. 
  • Generate reference documents and cleaning SOPs from the validated cleaning cycles. 
  • Ensure all systemic documentation gaps are identified and solutions are developed. 
  • Write technical cleaning evaluations as requested, including calculations such as maximum allowable residue carryover from product to product, and deviations with root cause and impact assessment. 
  • May perform other cleaning and sanitization validation related duties. 

Education and Skills Required:

  • Bachelor’s degree or greater in Engineering or sciences (demonstrated equivalent knowledge base may be considered). 
  • Able to apply fundamentals from various engineering disciplines (automated systems, sensor feedback, fluid mechanics, heat transfer, thermodynamics), materials (316 stainless steel and polymers), and chemistry (solubility, pH, conductivity). 
  • Familiarity with utilities (steam, USP water, pressured air, etc) associated with CIP Systems. 
  • Kaye Validator experience to support sanitization validation. 
  • Basic understanding of programming recipes and automated systems for cleaning validation. 
  • Proficient in the use for Microsoft Word, Excel, and Powerpoint.

Experience: 

  • 5+ years of experience in FDA regulated industries. 
  • Ability to assess data and write protocols and reports technically. 
  • Ability to execute cleaning and sanitization development and validation protocols independently following Good Documentation Practices (GDP) and communicate as part of a team.
  • Experience with CIP (Clean In Place) systems. Familiarity should include some of these topics: New fully automated CIP systems, Cleaning of Work-in-Progress (WIP) Tanks, Tank Cleaning, Cleaning of Product Transfer Line Piping Systems, Tote filling systems, Cleaning of High Volume Filling Systems, recipe programming and development, cleaning cycle development, cleaning validation, sanitization validation, swab and rinse sampling collection techniques, thermal sanitization, chemical sanitization, and troubleshooting cleaning issues. 

Position Details:

Consumer Product

Engineering

Start Date: 
6-23-2014
End Date: 
12-31-2014

Los Angeles, CA

CON_W2

DCCA31550

No

No