• Utilities Process Water SME

    Job Location US-KS-McPherson
    ID
    2018-3972
    # of Openings
    1
    Category
    Engineering
    Type
    Direct Hire
  • Overview

    To provide Utilities Engineering expertise specifically for the McPherson site water systems (cGMP and non-cGMP) e.g. softened, UV treated, reverse osmosis (RO), water for injection (WFI), plant steam and clean steam serving manufacturing and laboratory spaces.

    This role focuses on optimizing equipment and systems performance, improving reliability, driving continuous improvement, troubleshooting fault finding, asset replacement planning and system capacity planning.

    The job-holder works as part of a multi-functional Utilities team and will be expected to be flexible and agile in support of the group's overall mission.

    The role will include reviewing compliance documentation and regulatory audit attendance

    Responsibilities

    • ROLE RESPONSIBILITIES

      • Become the system matter expert (SME) for all cGMP and non-cGMP systems water based utility systems.

      • Become the first point of contact for all operational issues relating to these systems.

      • Own and contribute to investigations via Quality Tracking System (QTS)

      • Implement CI projects on all systems and ensure they are operating at optimum.

      • Approve systems changes under cGMP or GEP change management processes.

      • Monitor reliability and up time with the aim to improve systems by identifying gaps.

      • Oversee statutory inspections and minimize down time while maintaining compliance.

      • Gain a full understanding of the utilities systems interdependencies and the criticality of all GMP systems on site.

      • Develop capacity models for all systems and equipment and feed into the Site Master-planning process.

      • Engage with outside vendors where appropriate.

      • Develop asset lifecycle replacement plan, obtain funding and implement replacement projects.

      • Take responsibility for all aspects of Capex / Opex projects on the responsible systems incl. system design, installation, commissioning qualification and handover. Ensure all aspects are executed in line with Engineering standards and practices. No project changes are to be implemented on utilities systems without full oversight and approval.

      • Ensure all systems drawings and data are reviewed regularly and kept in an as-built state.

      • Complete periodic reviews as necessary.

      • Own and contribute to investigations via Quality Tracking System (QTS)

    Qualifications

    • QUALIFICATIONS

      Basic Qualifications :

      • BS in Engineering required, preferably in Mechanical, Chemical or Electrical with requisite experience.

      • Progressive experience (5-7 years) in pharmaceutical and/or related regulated industries in a management/leadership role

      • Working on full life cycle capital projects-from inputting to design specs through to handover to operations.

      • Demonstrated knowledge of mechanical and process systems employed in the pharmaceutical manufacturing process. Good working knowledge of applicable regulations and codes.

      • Knowledge of GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems).

      • In-depth knowledge of core principles across utilities engineering areas, facility design and Good Engineering Practice (GEP) is required.

      • Have worked in a sustaining, operations and/or project management role previously with extensive knowledge of how equipment design & handover should be influenced to improve reliability and start-up.

      Preferred Qualifications:

      • Prior experience of working as SME

      PHYSICAL/MENTAL REQUIREMENTS

      Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis

      NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

      First shift Monday through Friday. Some projects & initiatives may require evening and weekend work.

      Extended hours during the biannual plant shutdowns (summer & winter)

     

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