Validation Engineer II

ID# DCCA31131

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 OVERVIEW 

  • Familiarity / expertise with COP (Clean Out of Place) and parts washers. Familiarity should include most of these topics: COP cart design and spray nozzle placement, load pattern development, cleaning cycle development, riboflavin coverage studies, mock soiling, swab and rinse sampling collection techniques, thermal sanitization, and troubleshooting cleaning issues. 
  • 3-5 years of experience in FDA regulated industries. 
  • Ability to write protocols and reports technically. 
  • Execute protocols and record data following GDP. 
  • Able to interpret drawings for proposed COP carts in order to develop load patterns for parts cleaning. 

Job Description: 

  • The current project phase entails design work for cleaning thousands of small parts that are loaded onto COP carts and cleaned within the COP cabinets. Load patterns of the parts to be cleaned would first be developed and evaluated through coverage studies and then later validated using a master soil. 
  • Technical lead for small execution teams in performing cleaning cycle developments and cleaning validations. Shift and weekend work is an expectation during execution. 
  • Troubleshoot any COP cabinet issues affecting the cleaning developments and cleaning validations. 
  • Later project phases include leading small teams in cleaning validation execution. 
  • Generate cleaning SOPs from the validated cleaning cycles. 
  • Write technical cleaning evaluations as requested, including calculations such as maximum allowable residue carryover from product to product. 
  • May perform other cleaning validation related duties. 

Aptitude: 

  • Attention to detail, particularly in regards to execution, troubleshooting, and document writing. 
  • Self motivated, requiring minimal supervision. 
  • Communicates with stakeholders, escalates issues, and engages project partners. 
  • Aware of the needs of Operations as the customer and end-user. 
  • Organized in regards to project management and planning. 
  • Able to prioritize the sequence of multiple tasks to optimize the project schedule. 
  • Safety awareness. 

Preferred Education, Skills, Experience: 

  • Bachelor’s degree or greater in Engineering or sciences or demonstrated equivalent knowledge base. 
  • Able to apply fundamentals from various engineering disciplines (fluid mechanics, heat transfer, thermodynamics), materials (316 stainless steel and polymers), and chemistry (solubility, pH, conductivity). 
  • Experience with Girton parts washers preferred. 
  • Familiarity with utilities (steam, USP water, etc) associated with COP cabinets. 
  • Kaye Validator experience to support sanitization validation. 
  • Basic understanding of Allen Bradley or PLC controls. 
  • Proficient in the use for Microsoft Word, Excel, and Powerpoint. 

Position Details:

Consumer Product

Engineering

Start Date: 
4-1-2014
End Date: 
12-31-2014

LOS ANGELES , CA

CON_W2

40

DCCA31131

No

No