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Kedrion Biopharma, Inc. Engineering Manager in Melville, New York

Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

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.

Team Leadership

  • 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 conducting individual performance appraisals.

  • Work closely with HR for talent acquisition, onboarding, and ongoing professional development of team members.

Strategic Planning and Long-Range Vision

  • 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

Budget Management and Financial Planning

  • 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.

Capital Project Process Development

  • 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.

Project Planning and Development

  • 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.

Risk Managment and Mitigation

  • 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 lesson-learned repository to capture and apply insights from past project risks and mitigations.

Regulatory Compliance and Quality Assurance

  • 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.

Stakeholder Engagement and Communication

  • 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.

Continuous Emprovement Initiatives

  • 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.


  • Bachelor’s or master’s degree in engineering or a related field.

  • 10+ years of experience in project management and engineering, with a proven history 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.

Kedrion Biopharma offers a number of benefits to qualifying employees, including:

- Medical, vision and dental insurance

- Life and AD&D insurance

- Paid holidays

- PTO accrual

- and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Salary Range: $100k - $140k

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.