SR. PROJECT ENGINEER

Company: Kedrion Biopharma
Location: Melville
Posted on: October 16, 2024

Job Description:

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.

Keywords: Kedrion Biopharma, Plainfield , SR. PROJECT ENGINEER, Engineering , Melville, New Jersey