Senior Project Engineer

4 weeks ago

Melville, United States Kedrion Biopharma Inc. Full time

Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

The Senior Project Engineer provides project engineering for the Melville site with an emphasis on capital projects.

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 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.

Kedrion Biopharma offers a number of benefits to qualifying employees, including:

- Medical, vision and dental insurance

- Life and AD&D insurance

- Paid holidays

- PTO accrual

- and much more

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Salary Range: $125k - $160k

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.

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