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Automation/Validation Team Lead

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Insight Global

2021-12-03 07:32:03

Job location Kalamazoo, Michigan, United States

Job type: fulltime

Job industry: HR / Recruitment

Job description

Overview: 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:

  • Possess broad experience in a pharmaceutical environment with hands-on understanding of control and data acquisition systems, IT infrastructures, automated calibration and maintenance management systems, e.g. SQL Server, Wonderware System Platform, Siemens PLC, Allen Bradley PLC, Stabuli Robots, iFix, FTBatch, PlantPAX (Allen Bradley), FTView ME & FT View SE systems.
  • Lead and participate in development and execution of complete verification documentation in accordance with Quality Standards, cGMP requirements, and approved verification requirements/strategy related to the assigned work stream.
  • Will be responsible for review and approval of site documents to include calibration reports, batch records, SOP's, change control, and design specs.

Required Experience:

  • 5 years of experience related to verification and/or automation.
  • Proven background leading, training, and teaching teams of verification engineers to execute their work in aseptic environments including formulation, filling, and/or freeze drying.
  • 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 and automation experience related to drug product injectable operations, formulation, filling, or freeze drying.
  • Pharmaceutical background.

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