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Automation Engineer

Company: PQE Group
Location: Kalamazoo
Posted on: January 12, 2022

Job Description:

PQE is a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With a network of more than 900 consultants, PQE delivers the highest level of expertise to Life Science customers worldwide and has successfully completed 12,000+ projects for 1,400+ clients. An international group, PQE operates in over forty countries throughout Europe, Asia, and the Americas. PQE offers worldwide coverage with offices and representatives across Europe, North America, Asia, the Middle East, and Latin America, in order to better serve these specific local markets. Further information can be found at www.pqegroup.com.
Due to constant growth, PQE is looking for a new Automation Engineer. This will initially be an 8 month contract assignment that will be worked on site in Kalamazoo, MI with a possibility of extension.
Responsibilities

  • Provide project support of our automation systems, formulation equipment and formulation facilities in vaccine formulation and freeze facilities
  • Perform process engineering and automation activities to support equipment start-up, systems integration, process optimization, and cycle time reductions of our vaccine formulation facilities
  • Will likely be responsible for documentation development, SOP drafting, sequence of operation optimization and documentation
  • Follow standard operating procedures and standards in a highly regulated environment
  • Generate and execute protocols through GMP verification process
  • Develop new and follow existing standard operating procedures and programming guidelines
  • Design, develop, deploy and test our automated processes, systems and equipment
  • Contribute substantially to the interpretation of results and the design of subsequent activities
  • Maintain and support automation computing infrastructure
  • Adhere to safe work practices and develop standard operating procedures and system support documentation
  • Clearly communicate progress and issues to management and peers and finalize report writing for test protocols
  • Perform all tasks in strict compliance with operating procedures, best practices, and regulatory requirements
  • Provide feedback to leadership regarding potential issues and concerns with documentation
  • Accountable for accurately completing GMP documentation
    Requirements
    • At least 3 years of automation engineering experience in an FDA regulated GMP facility
    • Bachelor's degree in science, business, or related field
    • Seeking hands on experience with SQL Server, Wonderware System Platform, Siemens PLC, Allen Bradley PLC, Staubli Robots, iFix, FTBatch, PlantPAX (Allen Bradley), FTView ME, & FT View SE systems preferably related to verification of drug product injectable operations, formulation, filling, or freeze drying equipment, systems and start up
    • Previous work experience with PLC, SCADA, batch, and historian is required
    • Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and systems
    • Ability to manage priorities, deliverables, and schedule milestones
    • Requires strong interpersonal, verbal communication, and technical writing skills

Keywords: PQE Group, Kalamazoo , Automation Engineer, Engineering , Kalamazoo, Michigan

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