Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization.
Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Salary ranges are determined based on relevant experience, education, and certifications.
If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com.
Employee Benefits
At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including:
- Health & Wellness – Full medical, dental, and vision coverage
- Financial Security – Life insurance, AD&D, and retirement savings plans
- Work-Life Balance – Paid time off, sick leave, and paid holidays
- Career Growth – Training programs and development opportunities
- Extra Perks – Employee discounts, wellness initiatives, and more!
For specific inquiries please reach out to us
Job Description
The Project Engineer will be responsible for driving capital projects at the Melville site through all phases of project engineering. This includes initiating new initiatives, developing execution strategies aligned with business objectives, and conducting comprehensive cost-benefit analyses to support leadership in scope and budget decisions. The ideal candidate will possess strong project management skills, familiarity with modern engineering tools (e.g., AutoCAD, SolidWorks, MS Project), and experience with digital project tracking platforms (e.g., Asana, Jira).
Main Responsibilities
- 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.
- Make independent decisions within defined areas of responsibility.
- Collaborate very closely with all other Site Organizations, to ensure legal compliance of technical solutions 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.
- Performs any miscellaneous duties or work assignments, as required.
Requirements
- Bachelor’s degree in engineering.
- A minimum of 3 years of experience in 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.
- 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.
- 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.
Physical Requirements
- Ability to occasionally lift up to 25 pounds.
- Must be able to navigate manufacturing environments.
- Ability to sit or stand for extended periods.
Working Conditions
- Primarily inside with well-lit and well-ventilated areas.
Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.