Hikma Pharmaceuticals USA Inc.

  • Process Engineer III

    Job Location US-OH-Columbus
    Posted Date 1 month ago(9/17/2018 5:58 PM)
    Job ID
    2018-4804
    Job Function
    Manufacturing
  • Overview

    Lead continuous improvement through process optimization of physical Flow lanes (e.g. product life-cycle management, process troubleshooting, yield improvements) while ensuring compliance with government regulations and West-Ward Pharmaceuticals standards. Implement innovative new process, technology, quality, and compliance approaches (e.g. CIA and CAPA) at West-Ward Pharmaceuticals.

     

    Strengthen the process-related technical skill sets of Flow organization personnel through training and sharing of best practices.

     

    Provide leadership and mentoring to others within the organization.

    Responsibilities

    • Manage the life cycle of launched products on an assigned basis to support development of robust manufacturing processes, drive site right-first time metrics, and reduce product rejects.

    • Actively seeks out and identifies process optimization opportunities. Performs appropriate assessment of risk vs. benefit, participates in cross-functional assessments as required to evaluate opportunities, and implements improvements.

    • Collaborates with Physical Flow Coaches to drive shared business ownership and continuous improvement, particularly in regards to process performance (Zero Defects, RFT, Throughput Time, Physical Yield, etc.).
    • Partner with peers (e.g. Physical Flow, Equipment Optimizer, Quality Optimizer, and QAI) to lead root cause analysis and CAPA review, facilitating rapid closure of deviations and ensuring actions are taken to prevent recurrence.

    • Actively seeks out and identifies CAPA opportunities; pro-actively targets areas of potential risk. Evaluates opportunities for impact, cost effectiveness, and scope (e.g. applicability to other Flows and/or other West-Ward sites).

    • Actively support Flow lanes in the assessment, remediation, and investigation of deviations and significant atypical events. Provide first-line troubleshooting for process-related issues, respond with appropriate analysis, impact assessment, and path forward determination. Utilize troubleshooting and investigation experiences as opportunities to proactively drive CAPAs.
    • Advance the development of PCs through the collection and analysis of KPI’s, support of operator improvements, and facilitating improvements elevated to the APC.
    • Provide leadership and mentoring to facilitate the identification of process issues and implement sustainable solutions across multiple flow lanes, technologies, and across the organization, aligned with Site Metrics, Business Objectives and Site Strategy.
    • Effectively work (teach and mentor) with less experienced members of the Flow organization, toward the objectives of personal growth and enhanced job performance.
    • All other duties as assigned.

    Qualifications

    • B.S. in Biology, Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum 6 years of pharmaceutical experience, or
    • A minimum of 10 years of pharmaceutical experience, in an area that provides a knowledgeable background in pharmaceutical technology transfer, quality assurance, quality control, product development, or manufacturing.

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