Associate Specialist, Engineering - Pasuruan - Organon

    Organon
    Organon Pasuruan

    2 hari yang lalu

    Farmasi / Bioteknologi
    Deskripsi
    Job Description

    The Position

    IPT Engineer is responsible for supporting the operation team to ensure the target is achieved. They supervise technicians on troubleshooting, establish the maintenance process, manage equipment parts, develop, and supervise the correct operating system, develop, and supervise the operational team, and develop and ensure operational procedures reflect the operation. They also manage equipment parts, develop, and supervise the correct operating system, develop, and supervise the operational team, and develop and ensure operational procedures reflect the operation.

    Responsibilities

    Continuous Improvement
    • Maintain a working knowledge to support the execution of Continuous Improvement projects.
    • Perform production trials in support of process improvement or change control activities.
    • Promote culture of Continuous Improvement
    • Participating in continuous improvement activities and small projects

    Documentation
    • Prepare and execute SLC documents as required for new equipment or facilities assign to him/her.
    • Completes documentation (SOP, JA, WI, MWI, UAPR, PSR) within the production area regarding to the equipment's or facilities assign to him/her.
    • Coordinate and supervise of all deviations on production equipment under his/her responsibilities.
    • Coordinate an investigation of all product complaint under his/her responsibilities.
    • Perform Quality Risk Assessment for equipment under his/her responsibilities.
    • Supporting APR Data collection for equipment under his/her responsibilities.

    Equipment Operation
    • Organizes the team to operate continuously through all breaks and negotiates all exceptions through the Production Supervisor.
    • Supervise engineering shopfloor person to ensures seamless and effective shift handovers through face-to-face shift handover with the next shift/ Process Technician
    • Supervise engineering shop floor person to repair, set up, clean, changeover, adjust, maintain, troubleshoot, operate and any other tasks required to support operational requirements.
    • Supervise in tooling trials, installation, commissioning, and validation activities as required.

    Troubleshooting
    • Supervise to undertakes a hands-on troubleshooting role within specific areas of the electrical and appliances equipment, addressing operational problems with process equipment, including the direct use of tools.
    • Demonstrates a high level of competency in problem solving and troubleshooting mechanical breakdowns on hi-tech / hi-speed equipment in production situations.
    • Able to read and interpret complex drawings, schematics, and manuals to effectively operate and troubleshot manufacturing equipment.
    • Supervise on troubleshoot manufacturing and packaging functions using a variety of specialist equipment.

    Equipment Maintenance
    • Supervise and ensure to perform corrective and preventative maintenance in accordance with the site procedures and ensures that all follow up work is completed on time.
    • Supervise and ensures that preventative and programmed maintenance objectives are met within agreed time constraints.
    • Supervise engineering technician person to performs Equipment modifications where necessary.
    • Supervise engineering technician person to perform fault finding on equipment.
    • Supervise engineering person to identifies maintenance needs and trends.

    Manage Equipment and Parts
    • Supervise to inspect returned parts and ensure their condition does not affect the quality and productivity of production and place them in their correct storage location.
    • Supervise engineering person to correct the condition of any, missing, damaged or worn parts.
    • Supervise and ensure engineering technician person to assist operation staff with the changeover and set-up of production equipment.
    • Supervise and ensures that tooling and washbay are maintained according to 5S discipline.

    Calibration
    • Supervise engineering shop floor person to review related work orders (PMs) daily and closeout with agreed timeframes.
    • Supervise to maintain associated calibration and PM records in accordance with the cGMP.

    Knowledge Maintenance and Training
    • Maintain individual technical competence and expertise.
    • Provides technical advice as required and share best practices across IPTs and CoEs.
    • Liaise with all Engineers and with pertinent CoEs (i.e.: Engineering, etc.), sharing best practices; collaborate with peers at other sites - import best.

    Compliance/ Safety
    • Proactively support Permanent Inspection Readiness ensuring all documentation is made available during regulatory inspections and SMEs are available during inspections.
    • Implement all corrective actions are implemented in a timely fashion following regulatory inspections and internal audits.
    • Support Safety Investigations and corrective action implementation as requested.
    • Responsible to keep abreast site safety & quality requirement and specific compliance policy and standards at daily work.
    • Demonstrate quality leadership behavior, promotes a quality culture, and proactively supports cGMP compliance.
    • Promote the site SHE culture, including but not limited to, the interdependency safety culture.

    Requirements
    • Education : Bachelor's Degree polytechnics or universities with engineering major (mechatronic/chemical/mechanical is preferred)
    • Experience and Skills : At least 1 year of experience in the similar role with problem solving/ Root cause analysis, project management, MS office – especially excel, Proficient in English, Maintenance-Calibration experience.
    • Language proficiency : Business level of English and Native level of Indonesian

    Secondary Job Description

    Who We Are:

    Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

    As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

    Search Firm Representatives Please Read Carefully

    Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    Annualized Salary Range

    Annualized Salary Range (Global)

    Annualized Salary Range (Canada)

    Please Note: Pay ranges are specific to local market and therefore vary from country to country.

    Employee Status

    Regular

    Relocation:

    No relocation

    VISA Sponsorship

    Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

    Shift

    Flexible Work Arrangements:

    Valid Driving License

    Hazardous Material(s):

    Number Of Openings

    1

    Requisition ID:R538536

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