Senior Project Engineer

3 weeks ago


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

Kedrion Biopharma Inc. is a leading biopharmaceutical company dedicated to the development, production, and distribution of plasma-derived products. Our team is committed to delivering high-quality therapies for patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

Job Summary

The Senior Project Engineer provides project engineering expertise for the Melville site, focusing on capital projects. This role involves conceptualizing projects, developing execution strategies, and ensuring compliance with environmental, health & safety, and cGMP regulations.

Key Responsibilities
  • Develop project execution strategies to meet business objectives
  • Assure project compliance with related regulations
  • Provide technical engineering and capital project management expertise
  • Manage the project lifecycle, including project scope, user requirements, conceptual design, detailed design, installation, commissioning, validation, and operations handover
  • Collaborate with functional areas to ensure effective project execution
Requirements
  • Minimum 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
What We Offer
  • Medical, vision, and dental insurance
  • Paid holidays
  • Equal employment opportunities for all qualified applicants


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