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QC CSV Laboratory Validation Engineer - 1731
Job Description:

PSC is a leading life sciences consulting and IT services company. For over 19 years we have been engaged in providing project, process, IT, engineering and validation support to top-tier pharmaceutical and biotech companies.

 

Our client has an immediate opening for a QC CSV Laboratory Validation Engineer to help run the QC Lab Metrology Program in Oklahoma. Applicant will help lead implementation for the Water's Empower Software.

Responsibilities:
  • Run Lab QC Metrology program
    • Analytical Equipment
    • Calibration planning and execution
    • New equipment
  • QA Documentation Validation Review
  • Computer systems validation experience with knowledge in Part 11/ Annex 11
  • Generate and execute computer systems instruments qualification/validation protocols
  • Perform a gap analysis of existing QC equipment (analytical equipment validation) 
  • Creation, modification, and execution of validations (IQ, OQ, PQ)
  • Creation and modification of standard operating procedures (SOPs) and study protocols.
Requirements:
  • BS in analytical chemistry with a minimum of 3-5 years of experience, or MS with 1-2 years experience in analytical chemistry. 
  • Must have strong background and hands-on experience in HPLC, GC, Dissolution, UV/VIS, wet chemistry techniques common to the pharmaceutical industry.
  • Must have Empower experience
  • Strong oral and written communication skills are required. 
  • Knowledge and experience with regulatory requirements including FDA.
  • Good working knowledge of computer systems, including chromatographic data acquisition system (e.g. Empower), LIMS, MS Word, and MS Excel.

 

Job Listing Information
Job Code:
1731
Job Title:
QC CSV Laboratory Validation Engineer
Location:
Oklahoma
Number Of Openings:
1
Employment Duration:
Full-Time
Job Type:
Contract
Job Industry:
Biotech/Pharmaceutical
Work Experience:
Mid-Level
Date Posted:
04/26/2016


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