Job Details

  • Title: Validation Engineer I
  • Code: RCI-10481579
  • Location: Oceanside California (CA) 92056
  • Posted Date: 06/29/2020
  • Duration: 7 Months
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  Job Description

Relative Cleanability Studies
Support lab coupon studies to determine the cleanability new tech transfer products are compared to current products
Experience with lab scale studies and data analysis
Support pilot plant cleanability studies
 
Equipment Qualification
Support equipment qualification due to equipment modifications for tech transfers. Experience with IOPQs. 
 
Tech transfer activities
Writing Cleaning Confirmation or Validation Protocols and Reports
Execution of protocols by performing visual inspections, documentation (rinse samples by mfg)
Ideally have experience with Cleaning Validation as well as Deltav/PI
 
Additional 
Any deviations, anomalies or schedule impacting items are to be reported to site management. 
This position provides trained technical resources for the development and execution of validation protocols in accordance with OCN and global procedures. The person will maintain up-to-date training status in the Cornerstone (or equivalent) system. 
This position provides resources for the controlled collection, assessment and reporting of scientific validation or study data in support of validation of processes.  The data will be analyzed using algebraic and/or statistical methods to verify adherence to predetermined and approved process criteria.  Reports will be written to communicate the outcome of the studies and/or validations.
This position with provide sampling and inspection support for process equipment as part of the validation execution process.  As such, the person must be trained on sampling and inspection procedures; and may be called upon to provide training for others as needed.