Manufacturing Engineer
Listed on 2026-07-01
-
Engineering
Quality Engineering, Validation Engineer
Location: Saint Paul
Validation Lead
Location:
Oakdale MN - Minnesota
Note:
Look for people with either Electrical, Instrumentation or Mechanical background with must have experience in Analytical Instrument Qualification
Job Description
Experience in validating the Computerized System/Analytical Instrument. Extensive validation experience in 21 CFR Part 11.
Good understanding of GxP standards. Good knowledge in data integrity. Well acquainted with all the phases of Validation Life Cycle (VLC).
Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR).
Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions. Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.
Extensive experience in performing Risk Assessment. Good communication skills and English fluency.
Experience in validating few of this below equipment:
Particle Measurement System
• FT-IR Spectrophotometer
• Gas Chromatography
• Liquid Chromatography
• Carbon Dioxide Headspace Analyzer
Differential Scanning Calorimeter Metrohm UV-Vis Spectrophotometer Malvern Mastersizer Mass Spectrometer Tru Scan RM Analyzer MTS System Instron ICP-OES Spectrometer Mitutoyo Co-ordinate Measurement System TOC
- Total Organic Carbon Sensitech Temp Tale Manager Ellab Data Logger
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).