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    Sr. Operational Excellence Consultant - Philadelphia, United States - Network Partners Group

    Network Partners Group
    Network Partners Group Philadelphia, United States

    4 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Due to tremendous growth, Network Partners is looking for a Senior Operational Excellence Consultant to help continuously develop and enhance our portfolio of industry leading talent within the Pharmaceutical division.

    About us:

    Network Partners Group is a life sciences professional services provider whose purpose focuses on the support functions necessary to enable Medical Device, Pharmaceutical and Bio-Tech technologies to be marketed in the global marketplace.

    Responsibilities:

    • 8-12 Years of experience as a Process Improvement or Operational Excellence Program participant
    • Black Belt Certified in Lean/Six Sigma
    • Experience leading teams using the following tools:
    • Value Stream Mapping
    • Kaizen
    • Waste Reduction
    • SMED (Single Minute Exchange of Die)
    • PDCA (Plan, Do, Check, Act)
    • Six Sigma Methodology for reduction of variability in a process
    • Experienced in the Life Science Industry, preferably in a Packaging Manufacturing environment
    • Ensures that machines are properly maintained and PM's are performed and documented monthly.
    • Troubleshoot for all equipment in the department in collaboration with Packaging Mechanics when needed.
    • Contacts equipment vendors when mechanical problems arise.
    • Performs required analysis of all electrical, electronic and mechanical components in the event of equipment failure.
    • Hands on equipment validation and testing of expected mechanical performance against packaging requirements.
    • Establish and perform preventive maintenance on all equipment to ensure proper operation and minimal downtime.
    • Performs set-ups and changeovers of all machines in accordance with schedule demands.
    • Evaluate, recommend, develop and implement packaging materials/systems based on multiple factors and influence (i.e. operations, regulatory, marketing, quality, artwork, etc.)
    • Perform and/or coordinate material and packaging system testing as required by regulatory filing requirements.
    • Develop and execute test protocols and reports.
    • Collaborate with external customers and internal manufacturing sites on packaging development.
    • Support packaging component and/or equipment selection and validation.
    • Problem solve quality deviations that occur during manufacturing operations.
    • Participate in QA investigations when needed.
    • Collaborate with key stakeholders to provide technical assessments and support for key component changes.
    • Partner with Global Procurement to execute on aligned strategy, from vendor identification to implementation.
    • Manage scale up of new products, manufacturing feasibility batches, writing batch records and summarizing results.
    • Determine appropriate use of packaging equipment and processes to ensure acceptable product stability is obtained for all packaging operations.
    • Develop and execute studies for process, equipment, cleaning, facility, computer, and utility validation activities related to bulk drug delivery and finished dosage formulations developed by R&D and products currently in commercial production, customer and FDA requirements.
    • Update, review, and approve Standard Operating Procedures (SOPs) and other official documents and determine if validation or re-validation is needed prior to approval of new or changed procedures. Recommend new procedures or revisions were applicable.
    • Collaborate with validation projects within the facility including execution of protocols and report writing.
    • Support engineering department with capital projects or trouble shooting of equipment and processes within the facility.
    • Contributor of lean manufacturing and continuous improvement programs within the facility.
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