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    Engineering Project Coordinator - Lansdale, United States - System One Holdings, LLC

    System One Holdings, LLC
    System One Holdings, LLC Lansdale, United States

    2 weeks ago

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    Description
    Job Title: Engineering Project Coordinator

    Location: West point, PA

    Hours/Schedule: Mon- Fri 8am - 5pm

    Type: Contract

    Overview

    Leading Pharmaceutical Company looking for an experienced professional. Ideal candidates should have at least 2 years of
    work experience in the biological/ pharmaceutical/chemical manufacturing industry.

    Responsibilities
    • Establish and manage project schedules and timelines
    • Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
    • Responsible for stakeholder engagement, communication, and risk escalation.
    • Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
    • Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
    • Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
    • Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
    • Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
    • Provide technical support to manufacturing for problems and issues.
    • Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.
    Requirements
    • Bachelor's Degree in Engineering or Science
    • Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry
    • Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.
    • Minimum of six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.
    • Strong understanding of Change Control and Project management
    • Demonstrated ability to work both independently and as a part of a team
    • Strong technical problem-solving abilities
    • Demonstrated effective written and verbal communication skills
    • Strong collaboration skills
    • Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment
    • Experience with introduction of process changes to a licensed process
    Benefits

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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