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Langhorne

    Equipment Operator - Langhorne, United States - Penn Life Sciences

    Penn Life Sciences
    Penn Life Sciences Langhorne, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Department:

    Manufacturing

    Location:

    38 Cabot

    Job Title:

    Equipment Operator

    FLSA Status:

    Non-Exempt

    1. Role Purpose:

    With proper training, responsible for operation and cleanliness of all manufacturing machinery and equipment. Ensures that equipment is operated in a safe and effective manner to ensure that the production schedule is executed. Ensure that the manufacturing batch records are filled out as per the appropriate Standard Operating Procedures (SOPs).

    2. Key Duties & Responsibilities:

    • Ensuring the Batch records, Standard operating procedures and validation protocols are adhered to.
    • Perform tasks associated to operating manufacturing equipment including compounding, filling, inspection and packaging
    • Clean and Sanitize the clean room equipment per procedure
    • Ensure the cleanliness of manufacturing areas.
    • Ensure the assembling or set-up of process equipment or machines
    • Ensure the cleanliness of manufacturing equipment as per procedures (SOP's)
    • Actively involved in Batch manufacturing and process validations.
    • Will be trained for the execution of Batch records, standard operating procedures and validation protocols.
    • Interacting with Cross functional team personnel to attain the flow of activities with compliance.
    • Involved in preparation, participation of aseptic process simulation (media fill) activities and media fill planner according to respective protocol.
    • Involvement in performance verification of major processing equipment.
    • Report accidents, unsafe conditions or unusual circumstances to supervisor
    • Comply with FDA guidelines/Company Policies of Data Integrity
    • Understand and adhere to all cGMP and FDA regulations.
    • Other duties as required or delegated

    3. Education/Technical Competencies/ Certifications/ Licenses:

    • Able to operate pharmaceutical manufacturing equipment and machinery.
    • Continuous working knowledge of applicable cGMP guidelines
    • Education/Certifications/Licenses/Other
    • HS Diploma or GED
    • Associates Degree preferred
    • 1-5 years pharmaceutical manufacturing preferred
    • Ability to obtain Gown qualification

    4. Physical Demand and Work Environment:

    a. Physical demands:

    While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

    Company DescriptionPenn Life Sciences

    Company Description

    Penn Life Sciences
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