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Validation Engineer

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Insight Global

2021-12-03 13:57:59

Job location Kalamazoo, Michigan, United States

Job type: fulltime

Job industry: HR / Recruitment

Job description

Overview: Insight Global is looking for multiple Validation Engineers. This position is an 11-month contract beginning December 6th that will support an urgent global pharmaceutical manufacturing need related to drug product injection operations, formulation, filling, or freeze drying. Relocation assistance will be provided.

Shifts Available: 1st, 2nd or 3rd

Specific Responsibilities:

  • Support the validation/qualification of manufacturing equipment, facility and critical utility systems using tools/technologies such as SQL Server, Wonderware System Platform, Siemens PLC, Allen Bradley PLC, Stabuli Robots, iFix, FTBatch, PlantPAX (Allen Bradley), and FTView ME.
  • Possess strong process/mechanical/controls knowledge of key process equipment to include formulation systems, liquid filling, and/or sterilization processes.
  • Review product batch records and have the authorization/approval of procedures and other master production records, certificates of analysis, Board of Health protocols, certificates of compliance and change control assessments.

Required Experience:

  • 2+ years of validation or verification experience.
  • 2+ years of experience with 1 or more of the following: Allen Bradley PLC, Stabuli Robots, Siemens PLC, Wonderware System Platform,
  • 2+ years of experience with 1 or more of the following: SQL Server, iFix, FTBatch, PlantPAX, FTView ME, FT View SE Systems.
  • Experience with PLC, SCADA, batch, and historian.
  • BA/BS in Engineering or related field.

Additional Desired Experience:

  • Validation experience related to drug product injectable operations, formulation, filling, or freeze drying.
  • Pharmaceutical background.

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