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    Technical Operations Contractor - Lansdale, United States - Integrated Resources

    Integrated Resources
    Integrated Resources Lansdale, United States

    3 weeks ago

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    Freelance
    Description
    Job Title: Technical Operations Contractor

    Job Location: West Point, PA

    Job Duration: 9+ Months

    Payrate: $42/hour on W2

    Job Description
    • The Specialist is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture.
    • In this role, the contracted person will work as an individual contributor, may act as a team or project lead and lead work of others as required, as well as contribute to the performance and results of a department.
    • Additionally, this individual will provide technical guidance and anticipate and interpret needs to identify and implement solutions.
    Additional responsibilities include:
    • Establish and manage project schedules and timelines.
    • Determine project resource requirements and works with stakeholders to Product 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.
    Qualifications:

    Education Minimum Requirement:
    • Bachelor's degree in engineering or science
    • Required Experience and Skills:
    • 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.
    Preferred Experience and Skills:
    • 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.


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