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    Sr. Process Engineer - Lakewood, United States - Renaissance LLC

    Renaissance LLC
    Renaissance LLC Lakewood, United States

    1 month ago

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    Description

    Job Description

    Renaissance LLC

    All qualified candidates will be considered for this opportunity regardless of race, color, gender, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other protected status.

    Sr. Process Engineer

    US-NJ-Lakewood

    Job ID:
    Type: Regular Full-Time
    # of Openings: 1
    Category: Engineering/Facilities
    Lakewood, NJ

    Overview

    Responsible for assessing current processes and optimizing manufacturing equipment and systems to enhance efficiency, reduce expenses, and establish industry best practices within the production process by implementing systems engineering principles and technology from chemistry, physics, and equipment engineering.

    Responsibilities

    Minimum of 5 years' experience in designing processes and equipment for pharmaceutical manufacturing. Previous involvement in aseptic filling is advantageous. Tasked with ensuring the overall reliability of automated manufacturing lines and assisting in resolving equipment issues in a dynamic work environment. Also responsible for evaluating existing processes and optimizing manufacturing equipment and systems to lower costs, enhance sustainability, and establish best practices within the production process by applying systems engineering principles and technology from chemistry, physics, and equipment engineering.

    Function

    • Define and specify cGMP process equipment, piping, and controls for the development of products that enhance process capability and production volume while upholding and improving quality standards.

    • Participate in design assessments, site approval, and equipment installation.

    • Address issues with filling and packaging equipment and offer solutions to prevent downtime.

    • Develop and refine current processes and techniques for managing and troubleshooting manufacturing technical issues.

    • Ensure equipment uptime by promptly and effectively resolving production equipment problems to meet objectives for filling and packaging lines.

    • Address filling and packaging line problems related to equipment, personnel, materials, and quality. Lead the implementation of adjustments to resolve issues and prevent downtime.

    • Act as the technical authority in the designated area for filling or packaging.

    • Maintain reliable and secure manufacturing systems while boosting production rates, efficiencies, yields, costs, and changeovers.

    • Willing to work flexible shifts to support a 3-shift operation.

    • Coordinate and conduct engineering experiments, then compile reports and deliver presentations on the outcomes.

    • Draft documents to support projects, including project scopes, conceptual design presentations, capital requests, specifications, piping and instrumentation diagrams, process flow diagrams, timelines, requests for quotations, project expenses, project procedures, correspondence, start-up protocols, and cost estimates.

    • Support QA and Validation departments by creating design documents and aiding in protocol development and execution.

    • Assist in investigations of process equipment, utility systems, control abnormalities, and safety incidents.

    • Implement corrective/preventive measures for existing equipment and manufacturing processes.

    • Prepare change control documentation.

    • Revise and create procedures for the proper operation of new and/or existing equipment.

    • Propose and implement enhancements to operational efficiency for production lines using Lean principles.

    • Evaluate safety requirements and ensure their integration into the process.

    • Assist the Senior Manager in researching and acquiring new manufacturing technology and equipment.

    • Ensure projects are finalized on schedule.

    • Adhere to financial budgets.

    • Aid in the training of operations and maintenance staff as necessary.

    • Potentially oversee mechanical, electrical, and automation contractors as well as Maintenance mechanics, Contract Engineers, and Construction Contractors.

    • Fulfill other duties and responsibilities as assigned.

    Qualifications

    B.S. degree in Chemical, Biochemical, Equipment, or Mechanical Engineering is mandatory. Preferably, three years of relevant experience in the pharmaceutical sector.

    Must have:

    • A comprehensive understanding of cGMPs and sanitary equipment design requirements;
    • An advanced knowledge of engineering documentation necessary for cGMP process equipment; and
    • A substantial knowledge of clean room design and function.

    Compensation details: Yearly Salary

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