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Process Engineer

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Omrix Bio-pharmaceuticals is seeking a Process Engineer for the Technical Group in our Tel-Hashomer site.

Scope: Utilizing sound scientific and engineering principles for problem solving and execution of continuous process improvements within the context of cGMP practices.

This is a full time temporary position covering a maternity leave.

Responsible for providing advanced engineering, design, and construction of manufacturing facilities, systems, and equipment; and providing engineering and technical support for complex production and processing equipment. Develops process excellence techniques to identify systematic issues. Tracks trends, develops and implements equipment and/or process enhancements that will improve efficiency, product yield, and equipment reliability. Leads in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities. Reviews evaluations and advice on the selection of suitable equipment for optimized, balanced line performance and report final recommendations to senior management. Ensures that process and material quality objectives are met during product launch and are congruent with production requirements. Establishes process and material quality targets. Reviews performance measurements to targets and provides remedial action directives as necessary. Generates capital equipment appropriations required for new process implementation and controls expenditures to ensure compliance with timing and budget requirements. Provides technical leadership of cross functional teams on many different process improvements.

Duties & Responsibilities:

  •   Lead technical BB support which can range from tactical improvement programs impacting supply sites or function to very complex, strategic initiatives
  •   Performing an on-going manufacturing process evaluation, identification of potential manufacturing risks and proposal of preventive actions with regards      to process changes
  •   lead cross functional teams in a matrix environment to identify and recommend the best enterprise business proposition across product development          Supply Chain and Commercialization
  •   Product portfolio/project mgmt., leading short and long term technical projects from concept to implementation: Development, Engineering,                    characterization, PQ, PPQ and submission
  •   Deliver transparent, timely and effective verbal and written communication to teams, stakeholders and appropriate levels of the organization
  •   Develops systems and processes regarding collection of data, analysis and reporting of production process trends, for example: Yields, OOS, and                Deviations
  •   Conducts process related root cause investigations and management of process related CAPA
  •   Performs on-going manufacturing process evaluation, identification of potential manufacturing risks and proposal of preventive actions with regards to          process changes.
  •  Reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology.
  •   Leading risk assessment of manufacturing changes (pFMEA), and process trending (Criticality analysis CPP’s, CMA’s, CQA’s) to support appropriate controls and mitigation strategies, establishing a comprehensive risk management plan for both product and process performance.
  •   Evaluation and ownership of process related changes.
  •   Review of manufacturing procedures for compliance with quality standards and regulations and implementation of improvement opportunities
  •   Providing manufacturing subject matter expertise to support Process validations and Process Qualifications
  •   Provide leadership and support according to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking.
  •   Communicate effectively at different levels and across different functions within the organization
  •   Responsible to work in conjunction with Manufacturing, Quality Assurance, Engineering, Regulation and Validation departments to support and troubleshoot existing operations, provide recommendations for process improvements.

Qualifications:

  •   BSc/MSc in Bio-engineering field – Mandatory
  •   At least 3 years in a technology/scientific engineering position – Mandatory
  •   Proven project management experience in a pharmaceutical (GMP) industry – Mandatory
  •   Ability to interpret and communicate technical information into business language.

אומריקס הינה חברה ביו-טכנולוגית המייצרת ומפתחת מוצרים מצילי חיים ב- 2 תחומים: ביוכירורגיה וחיסונים פאסיביים. החברה נוסדה ב 1995 ומתמחה בפיתוח וייצור של מוצרים ביוטכנולוגיים מתקדמים מפלסמה אנושית. אומריקס מועסקים מעל 500 עובדים בישראל, בשלושה אתרים מרכזיים: תל השומר, הר החוצבים ירושלים ונס ציונה.

הגעת לתפריט הנגישות, לחץ ENTER על מנת לדלג על התפריט.