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    Engineering Manager - New York, United States - Kedrion Biopharma Inc.

    Kedrion Biopharma Inc.
    Kedrion Biopharma Inc. New York, United States

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Scope:
    The Manager of Engineering is responsible for the engineering program at the Melville site. He/She will be responsible for managing, coaching, and developing engineering personnel.

    Responsibilities also include maintaining 5-year Capital Project Plan and budget, project management (for expansions, compliance, sustainability, continuous improvement Projects, etc.) in all stages of planning, design, execution, commissioning and handover to end user, shutdown activity schedules and Reliability Engineering.

    Ensures department policies, SOPs and training are up to date, efficient and effective.


    Main Responsibilities:
    Provide visionary leadership to the Engineering team, setting clear expectations, goals, and objectives.

    Implement talent development strategies to enhance the capabilities of the team, including training programs, mentorship initiatives, and professional development opportunities.

    Foster a culture of collaboration, innovation, and accountability within the team.
    Drive performance within the teams by setting SMART objectives and monitor progress by carrying out individual performance appraisals.
    Work closely with HR for talent acquisition, onboarding, and ongoing professional development of team members.

    Develop a comprehensive, forward-looking asset strategy for the Melville site that aligns with the organization's overall mission and strategic objectives.

    Manage 5-Year Capital Project Plan ensuring projects are well described, scope is well defined and properly categorized (Expansion, Compliance, Sustainability, Continuous Improvement, etc.).

    Collaborate with executive leadership to understand business priorities, market dynamics, and potential areas for future expansion.
    Establish key performance indicators (KPIs) to measure the success and impact of the long-range vision.
    Develop and manage the capital projects budget, ensuring accurate financial forecasting, cost control, and alignment with organizational priorities.
    Collaborate with the finance team to align project expenditures with financial goals and strategic objectives.
    Implement strategies to optimize financial outcomes, such as cost savings initiatives and value engineering.
    Provide transparent financial reporting to executive leadership and stakeholders.

    Lead the design and implementation of a robust and standardized capital project development process, incorporating best practices and lessons learned from past projects.

    Develop and refine methodologies, tools, and templates to streamline project initiation, planning, execution, monitoring, and closure.
    Integrate sustainability and innovation principles into the project development process, ensuring alignment with environmental and industry standards.
    Ensure compliance with Global Engineering Standards and Procedures
    Establish a feedback loop for continuous process improvement based on project outcomes and industry advancements.
    Oversee the comprehensive planning and development of capital projects, ensuring alignment with organizational goals and financial objectives.

    Collaborate with cross-functional teams, including engineering, operations, finance, and regulatory affairs, to conduct in-depth feasibility studies, risk assessments, and cost-benefit analyses.

    Develop and manage project budgets, providing financial oversight throughout the project lifecycle.
    Implement project management methodologies that emphasize efficiency, quality, and timely delivery.
    Implement a comprehensive risk management strategy for capital projects, identifying potential risks and developing mitigation plans.
    Foster a proactive risk management culture within the team, encouraging ongoing risk identification and assessment.
    Conduct real-time adjustments to project plans based on evolving risk factors, ensuring project timelines and budgets are safeguarded.
    Establish a lessons-learned repository to capture and apply insights from past project risks and mitigations.

    Ensure that all capital projects strictly adhere to state and federal codes, and all regulatory standards - including FDA standards, and Good Manufacturing Practices (GMP).

    Collaborate closely with the Quality Assurance team to integrate quality standards into the project development process.
    Proactively identify and address potential regulatory challenges, providing solutions to maintain compliance.
    Participate in regulatory audits and inspections, providing necessary documentation and ensuring adherence to regulatory standards.
    Cultivate strong relationships with key stakeholders, including executive leadership, operations, maintenance, regulatory affairs, and external partners.
    Communicate project progress, challenges, and strategic insights to stakeholders through regular updates, presentations, and reports.
    Establish a feedback mechanism to gather input from relevant departments and stakeholders, ensuring alignment with organizational objectives.
    Facilitate collaborative decision-making processes that enhance project success.
    Provide support and technical expertise to the EMU, Production, Validation, Quality Operations, and QC Departments.
    Lead and actively participate in continuous improvement initiatives to enhance the efficiency and effectiveness of the capital project process.
    Stay abreast of industry trends, emerging technologies, and best practices, evaluating their applicability in driving improvements in project development.
    Drive innovation and sustainability initiatives within the capital projects portfolio, integrating eco-friendly practices and state-of-the-art technologies.
    Establish a culture of continuous learning, encouraging the team to apply lessons learned from past projects to future endeavors.


    Qualifications:
    Bachelor's or Master's degree in Engineering or a related field.

    10+ years of experience in project management and engineering, with a proven track record of successful leadership in capital projects.

    Strong strategic thinking and long-range planning capabilities.
    Experience in the pharmaceutical or biopharmaceutical industry, with knowledge of FDA regulations and GMP.
    Exceptional leadership and team management skills.
    Excellent communication and stakeholder engagement abilities.
    Proven ability to drive results, achieve financial goals, and optimize project outcomes.
    Collaborative and inclusive leadership style.
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