Manufacturing Specialist I
Hospira - Clayton, NC

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Hospira is the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees.

The Hospira Clayton operation has an opening for a Manufacturing Specialist I.

Reporting to the Manufacturing Team Improvement Manager, this position will

  • Support the Manufacturing operation through the direct oversight of ER generation of non-conformances, the resolution of operational issues, and the generation of appropriate CAPAs to drive improvements in the business;

  • Assure all Standard Impact Reviews are aligned between Corporate and local documents, lead change controls required to support the manufacturing operation, assure all Manufacturing SOPs are reviewed on a biennial basis, and monitor the effectiveness check process;

  • Require working with engineering on Capital projects, maintenance on PMs and repairs to equipment and with direct floor supervision to ensure the implementation of equipment design and production procedures and records work seamlessly together;

  • Provide guidance to less senior Manufacturing Specialists related to the transitioning of new projects/processes within the Manufacturing operation.

  • Other functions of the position are to evaluate improvement opportunities, perform analysis of operations and the ability to identify and quantify compliance and cost improvements. This includes the evaluation of the effective use of labor, cross functional activities to support the operation, manufacturing capital project representative and improving flow and optimizing efficiency within the Manufacturing area.


  • Technical Knowledge : Responsible for authoring low, medium and high level investigation reports; Generate and deliver training materials on scientific or technical aspects of the process; Review process/equipment/system failures through Root Cause Analysis; Participate in the assessment or implementation of special projects or initiatives; Provide process troubleshooting support in assigned manufacturing area

  • Leadership: Provide guidance to less senior Manufacturing Specialist(s) by providing technical expertise and general leadership qualities; Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

  • Continuous Improvement: Assess process performance by observation of floor operations and review of performance data; Evaluate, plan, and implement solutions for process improvement opportunities ; Ensure Investigations are accurate and thorough and submitted within the established timelines; Assure effective CAPAs are initiated to drive continuous improvement in responsible areas.

  • Process/Operational Understanding: Provide oversight in the resolution of manufacturing operational issues in Formulation, Filling, Sterilization, or Packaging; Have a sound understanding [specific areas] in order to assure alignment between Corporate and local documents; Serve as document owner for manufacturing procedures and batch records for the four manufacturing operations; Monitor the effectiveness of changes in the four manufacturing operations; Support collection and analysis of annual product quality review; Participate in the New Product Introduction process to assess requirements for documentation, materials, training, and equipment modifications; Lead or assist manufacturing change owner on Change Control packages impacting the process; Ensure compliance with corporate guidance and all regulatory agencies and facilitate formal responses to audit observations; Perform clean area audits as directed; Oversee engineering studies within your respective manufacturing area.

  • Skills/Experience Education/Certification
    · Bachelors Degree required; preferably in Engineering.
    · A minimum of 7 years of hands-on Pharmaceutical plant experience in a GMP environment.
    · Deep understanding of the interaction of production documents with equipment functionality.
    · Knowledge of terminal sterilized or aseptic, barrier (RABs), or isolator technology for parenteral filling operations.
    · Experience working with the formulation and filling of parenteral products, including container closure systems, as well as the sterilization and primary/secondary packaging, etc.
    · Demonstrated ability to solve complex technical problems and implement solutions.
    · Strong interpersonal and communication skills to be effective in a team based situation.
    · Sound working knowledge of cGMPs.
    · Excellent written and verbal communication skills.
    · Demonstrated ability to objectively analyze situations and evaluate alternatives
    · Be able to present to management in a concise, fact based manner.
    · Effective multi-tasking is a must for this position.
    · Possess a good working knowledge of financial metrics to allow for the ability to estimate financial benefits for improvements.
    · A demonstrated ability to be a change agent.
    · Must have exceptional skills at working within groups and the ability to effectively influence them.
    · Six Sigma or equivalent certification is a plus.
    · Must be able to identify and analyze problem situations and develop and implement corrective programs and policies.
    · Must have an objective point of view when analyzing projects.
    · Fundamentally, this position will be held accountability for seamless execution of manufacturing unit operations. The individual must be able to determine root cause and effective corrective action implementation. The individual must also be able to quantify benefits associated with recommended improvement changes. The individual must also be able to effectively assist to manage the culture associated with any changes being implemented. The individual must be able to build consensus and get buy-in on best strategies and action plans associated with them. The individual must be able to effectively manage numerous and complex projects, responsibilities, and deadlines
    · Ensure compliance with all global regulatory agencies including FDA as well as Hospira corporate policies and procedures.

    Hospira - 18 months ago - save job - block
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    About this company
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    Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...