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Hightstown

    Process Engineer - Hightstown, United States - Synerfac

    Synerfac
    Synerfac Hightstown, United States

    1 month ago

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    Description

    Details:

    Responsibilities:

    • Responsible for maintaining all manufacturing equipment (washing, sterilization tunnel, vial filling and capping machine, Lyophilizer, Autoclave, packaging machines and plant utility systems including, heating, ventilating and air conditioning systems (HVAC).
    • Upkeep of the plant including clean rooms and clean utilities (purified water system, WFI generation system, pure steam generation system /plants including control systems.
    • Day to day engineering support across functional department for continuous operation.
    • Documentation for routine maintenance and records as per cGMP requirement.
    • Schedule activities based on priorities and ensure all documentation is compliant with Good documentation practices.
    • Understand quality systems including Change Control, Deviations, CAPA"s and FMECA.
    Schedule and coordinate periodic maintenance work and maintain spares and consumables for min-max and re-order levels.

    • Plan calibrations activities with internal /external agencies as applicable.
    • Increase Safety Awareness and address any safety issues and concerns and ensures that equipment meets all relevant Health, Safety and Environment requirements.
    • Participate in validation activities and their documentation such as Validation Summary Report (VSR) as per GXP Regulations (GMP, GAMP).
    • Optimize the process by introducing new technology, automation and their implementation.
    Perform Gap Analysis and Remediation plans.

    • Responsible for the entire life cycle of equipment Validation including User Requirements Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment and System Design Specifications (SDS).
    Job Requirements


    Details:

    Qualifications:

    • 4 Years of related experience in the Pharmaceutical Sector
    • Ability to upkeep the Manufacturing & Facility equipment's and related documentation.
    • Process optimization by introducing new technology, automation, and their effective implementation.
    • Experience with Microsoft Office products, such as Excel, Word, and Outlook.
    • Able to write SOP (standard operating procedure) using equipment manuals and executing IQ/OQ/PQ protocols.
    • Ability to work independently with minimal direction and supervision.
    • Must be able to communicate effectively with departmental staff, both written and verbal.
    • A strong work ethic, integrity, stability, sense of urgency, fairness, and a desire and willingness to take ownership and assume responsibility for the operation.
    • Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take transfer sponsorship of an employment Visa at this time

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