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Process Engineer

Company: PQE Group
Location: Kalamazoo
Posted on: January 16, 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 Process 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 in the installation, pre-commissioning and maintenance of equipment/utilities/ancillaries, used in vaccine formulation, fill & finish and freeze-drying processes
  • Perform process engineering 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
  • Contribute to design, develop, deploy and test our automated processes, systems and equipment
  • Contribute substantially to the interpretation of results and the design of subsequent activities
  • 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 related process engineering experience, with preferred experience in aseptic environments including formulation, filling, freeze drying, and/or bio-tech, with understanding of automated process equipment, systems architecture and operations, and related components
    • One year process experience in a pharma GMP environment strongly preferred
    • Must have hands on experience with the above processes equipment/utilities start-up (e.g. pre-commissioning), troubleshooting, and operations experience (e.g. preventive/corrective maintenance)
    • Previous experience in equipment and process and equipment validation is helpful, but not just focusing on this
    • Technical expertise in GMP biotech processes that include upstream & downstream manufacturing
    • Ability to manage priorities, deliverables, and schedule milestones
    • Requires strong interpersonal, verbal communication, and technical writing skills

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

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