Sr. Project Engineer

3 months ago

Melville, United States Kedrion Biopharma Full time

Scope: The Project Engineer provides project engineering for the Melville site with an emphasis on capital projects. Refrigeration experience a plus.


Main Responsibilities

  • Conceptualizes projects and develops execution strategies to meet the business objectives. Develops options with cost benefits analysis to assist site leadership to identify the appropriate project scope and budget.
  • Assures that projects comply with related environment, health & safety, and cGMP regulations. Maintain compliance with state and federal codes.
  • Provides technical Engineering and Capital Project management expertise for the design, and implementation of manufacturing processes, instrumentation, and equipment
  • Capital management expertise includes managing the whole project lifecycle Project Scope, User Requirements, Conceptual Design, Detailed Design, Installation, Commissioning, Validation, Operations Handover)
  • Build effective and collaborative relations with all functional areas in the plant.
  • Perform design studies, engineering test plans, troubleshooting, submitting Change Control Requests, and coordinating efforts with QA, Regulatory, Safety, Production, Validation, and Maintenance.
  • Provides conceptual design and estimates, including construction, commissioning, and start-up of equipment to execute the project.
  • Maintains current knowledge of developments related to manufacturing and applies that knowledge to company goals.
  • Makes independent decisions within defined area of responsibility.
  • Collaborate very close with all other Site Organizations, to ensure legal compliance of technical solution adopted for projects execution.
  • Manages cost throughout detailed cost report\
  • Manages schedule throughout proper scheduling tools like “project”
  • Prepares Monthly status reports for his projects which include milestones reporting, risks reporting, cost reporting



Background and Experience:

  • A minimum of 7 years of experience in a biopharmaceutical, or food, or OTC consumer industry in a role as project engineering. Certified Facility Manager (CFM) and/or Project Management Professional Certification (PMP) a plus.
  • Bachelor’s Degree in Engineering.
  • Deep knowledge of Microsoft Office, AutoCAD, 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.


Knowledge, Skills, and Abilities


  • 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.

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