Project Manager

5 days ago

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

At 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, including conceptual design and cost benefit analysis.
  • Ensure compliance with environmental, health and safety, and cGMP regulations, as well as state and federal codes.
  • 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 and collaborate with cross-functional teams.
  • Perform design studies, engineering test plans, troubleshooting, and submit change control requests.
  • Provide conceptual design and estimates for construction, commissioning, and start-up of equipment.
  • Maintain current knowledge of manufacturing developments and apply that knowledge to company goals.
  • Make independent decisions within defined areas 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, including milestones, risks, and cost reporting.

Requirements:

  • A minimum of 3 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 cGMPs, 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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