Project Engineer

6 days ago

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

Kedrion Biopharma Inc. is a leading biopharmaceutical company that specializes in the development, production, and distribution of plasma-derived products. We are seeking a highly skilled Project Engineer to join our team at our Melville site.

Main Responsibilities:
  • Conceptualize projects and develop execution strategies to meet business objectives.
  • Develop options with cost benefits analysis to assist site leadership in identifying the appropriate project scope and budget.
  • Ensure that projects comply with related environment, 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 whole project lifecycle, including project scope, user requirements, conceptual design, detailed design, installation, commissioning, validation, operations handover, and cost management.
  • 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.
  • Provide conceptual design and estimates, including construction, commissioning, and start-up of equipment to execute the project.
  • Maintain current knowledge of developments related to manufacturing and apply that knowledge to company goals.
  • Make independent decisions within defined areas of responsibility.
  • Collaborate closely with all other site organizations to ensure legal compliance of technical solutions adopted for project execution.
  • Manage cost throughout detailed cost reports and manage schedule throughout proper scheduling tools.
  • Prepare monthly status reports for projects, including milestones reporting, risks reporting, and cost reporting.
Background and Experience:
  • A minimum of 3 years of experience in a biopharmaceutical, 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, 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.

Kedrion Biopharma Inc. offers a competitive salary range of $95k - $125k, based on relevant experience, education, and certifications. We are an equal opportunity employer and welcome applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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