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    Packaging Implementation Coordinator - Durham, United States - BPM Associates

    BPM Associates
    BPM Associates Durham, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    BPM Associates - Helping Life Science Companies Design, Manage, and Execute Their Most Complex Projects.

    BPM Associates is a life sciences consulting firm focused on complex project implementations for the Life Science industry. At BPM, we believe in the power of extraordinary people working together in a great environment to accomplish important, lasting change. LOCAL CANDIDATES ONLY. NO RELOCATION AVAILABLE.

    Responsibilities

    1. Comply with client assigned GMP training curricula on consistent basis
    2. Provide escort to contractors into and out of clean manufacturing space (CNC space) within the client building.
    3. Ensure all contractors and self-comply with CNC gowning requirements.
    4. Ensure tools and materials to enter or leave CNC space is clean/covered and complies with CNC requirements.
    5. Monitor contractors to ensure proper gowning process are being followed.
    6. Point of contact for activities required to prepare and install OEM equipment for the packaging line and connection to the central palletizer system. Coordinate OEM details with General Contractor to ensure seamless equipment installation upon arrival.
    7. Support the Project Manager as needed by coordinating schedule development and updates, scope tracking and updates, risk and issue management.
    8. Coordinate creation and management of project deliverables such as Health, Safety and Environmental (HSE) plan, project RACI (roles and responsibilities), Risk Analysis, and Parts Plan.
    9. Keep track of lessons learned and share those lessons with team members.

    10.Support project collaboration site (e.g. Teams, SharePoint).

    Qualifications

    1. Ability to use computers and Microsoft and other assigned software (Training software)
    2. Ability to communicate in clear, concise direction to others
    3. Ability to direct others to comply with established processes
    4. Ability to seek assistance when required
    5. Ability to escort and monitor a number of contractors (est. 10) at once
    6. Ability to provide solutions to unexpected situations
    7. Ability to multitask and prioritize a variety of tasks within a timeframe
    8. Experience in manufacturing or construction

    Desired (but not required):

    1. Working understanding of capital project asset delivery, automation, engineering, medical device manufacturing, and validation
    2. Working knowledge of GxP requirements, including Good Documentation Practices, and requirements for working in Clean Spaces
    3. Working knowledge of best personnel safety practices in construction and manufacturing
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