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    Manager, Engineering - Rockville, United States - Latitude, Inc.

    Latitude, Inc.
    Latitude, Inc. Rockville, United States

    2 weeks ago

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    Description

    Job Description

    This role supports projects at the site and ongoing validation efforts. The main tasks include designing, authoring, and executing commissioning, qualification, and validation studies in various key disciplines:

    • Facilities, Utilities, and Equipment (FUE) qualification
    • Units operations automation qualification
    • Computerized systems validation
    • Cleaning validation
    • Sterilization validation
    • Materials validation
    • Process validation

    Responsible for ensuring projects are completed successfully in terms of quality, time, and budget. Using significant technical knowledge, this role reviews and approves complex design concepts, provides guidance to staff, and is acknowledged as an expert in the field. Demonstrates a solid understanding of theories and practices across various validation disciplines.

    Key Responsibilities:

    • Manages complex issues in projects, plans project implementation, and defines scopes of work
    • Reviews and approves design concepts, technology analyses, and project cost estimates
    • Provides leadership in assessing validation and compliance requirements, guiding validation strategies, and approving protocols and documentation
    • Prepares regulatory submissions and supports the development of best validation practices
    • Leads projects with unique features and takes on other necessary responsibilities

    Qualifications:

    • Bachelor's degree in science, engineering, or related field
    • Minimum 3 years of experience in a GMP regulated environment, with 3 years of commissioning, qualification, and validation (CQV)
    • 2 years of professional supervision and project management experience
    • Knowledge of industry guidelines and regulations, validation practices, and system experience in specific areas
    • Strong project leadership, communication, and influencing skills
    • Direct experience in manufacturing operations and biotechnology processes
    • Authorized to work in the United States without visa sponsorship

    Additional Characteristics:

    • Excellent communication and attention to detail
    • Strong organizational and writing skills
    • Proficiency in Microsoft Office tools
    • Self-motivated, problem-solver with effective leadership and supervisory abilities
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