PROCESS ENGINEER – STERILE

Job Purpose: To provide engineering support to the R&D Sterile Fill Finish function, in the design, commissioning and qualification of equipment and processes to facilitate the manufacture of new and existing products.

Responsibilities of the role include:

Engineering

  • Provide engineering support to R&D Sterile Fill Finish development teams and projects
    • Develop and support new manufacturing processes and technologies
    • Understand equipment operation in detail
    • Define and review equipment specification and associated test documentation.
    • Support project delivery through FAT, SAT and IOQ involvement as needed
    • Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing)
    • Identify means to improve processes, increase efficiencies and reduce costs
    • Strong focus on disciplined root cause analysis
    • Liaise with vendors on disposable technology and integration into the process
    • Development of process cleaning and sterilization cycles
    • Development of critical process parameters for the process and development of process capability and deviation monitoring
    • Monitor process risk and ensure mitigations are in place as required
    • Benchmark other industries and organizations to ensure best practice is in use.
    • Be active in the network, attending conferences/training seminars as needed.

Health, Safety and the Environment

  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
    • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.

Quality Compliance

  • Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
    • Take ownership for quality compliance in all activities under the responsibility of the role

The ideal candidate for the role will:

  • Be qualified to a minimum of Degree level in engineering or related discipline
  • Have minimum 1 year of Process Engineering experience within a relevant Pharma environment (preferably within a sterile manufacturing environment)

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