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    Melville, New York, United States Kedrion Biopharma Inc. Full time

    Project EngineerAt Kedrion Biopharma Inc., we are seeking a highly skilled Project Engineer to join our team. The successful candidate will be responsible for providing project engineering services for our Melville site, with a focus on capital projects.Main Responsibilities:Develop and implement project execution strategies to meet business objectives,...

Project Engineer

1 month ago

Melville, New York, United States Kedrion Biopharma Inc. Full time
Job Title: Sr. Project Engineer

At Kedrion Biopharma Inc., we are seeking a highly skilled Sr. Project Engineer to join our team. As a key member of our project engineering team, you will be responsible for providing project engineering support for capital projects at our Melville site.

Key Responsibilities:
  • Develop and implement project execution strategies to meet business objectives.
  • Ensure compliance with environmental, health & safety, and cGMP regulations.
  • Provide technical engineering and capital project management expertise for the design and implementation of manufacturing processes, instrumentation, and equipment.
  • Manage the project lifecycle, including project scope, user requirements, conceptual design, detailed design, installation, commissioning, validation, and operations handover.
  • Build effective relationships with functional areas in the plant.
  • Perform design studies, engineering test plans, troubleshooting, and coordinating efforts with QA, Regulatory, Safety, Production, Validation, and Maintenance.
  • Provide conceptual design and estimates for construction, commissioning, and start-up of equipment.
  • Maintain current knowledge of developments related to manufacturing and apply that knowledge to company goals.
  • Makes independent decisions within defined area of responsibility.
  • Collaborate with site organizations to ensure legal compliance of technical solutions adopted for project execution.
  • Manage cost and schedule throughout the project lifecycle.
  • Prepare monthly status reports for projects, including milestones, risks, and cost reporting.
Requirements:
  • A minimum of 7 years of experience in a biopharmaceutical, food, or OTC consumer industry in a project engineering role.
  • Certified Facility Manager (CFM) and/or Project Management Professional Certification (PMP) a plus.
  • Bachelor's Degree in Engineering.
  • Deep knowledge of Microsoft Office, AutoCAD, and Microsoft Project.
  • Knowledge of FDA cGMP's, Federal, State, and Local Environmental regulations, standard operating procedures, QA/QC documentation, equipment validation, equipment specifications, factory acceptance testing, site acceptance testing, equipment start-up and commissioning.
Preferred Skills:
  • Strong communication and organizational skills.
  • Demonstrated ability to effectively prioritize and coordinate functions and activities.
  • Excellent project management skills and comfortable with project management tools.
  • Problem-solving skills, results-oriented.