Grand Island, NY, United States
Area of Interest
About Fresenius Kabi
Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 30,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.
Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.
This position is responsible for providing the managerial and technical expertise necessary to direct the efforts of a project team. The project team consists of contractors from various crafts as well as members of department as assigned. Responsibilities include analysis, recommendation, implementation, cost justification and follow-up on projects designed to increase or improve productivity, capacity, or safety.
d product transfer process design and development.
Organizes and analyzes product specific data to design core processes according to product requirements.
Calculates and organizes data for process flow diagrams including instrumentation and control considerations.
Develops P&IDs and 3D Models of process skids and equipment as well as corresponding shop drawings and isometric drawings for field assembly.
Develops process specifications for formulation of conventional small molecule injectable as well as emulsion and complex formulation, including equipment skids, product delivery systems, pressure vessels, pumps, compressors, heat exchangers and all associated equipment.
Prepares specifications and process instructions to operate equipment.
Analyzes production and processing problems and initiate project definitions to resolve them.
Ensures timely and within budget completion of the projects as assigned by his/her manager.
Evaluates the feasibility of conceptual projects and prepares detailed analysis, including time and cost for completing the projects.
Assures that assigned projects are in compliance with State, Federal and local codes which encompass environmental protection, FDA requirements, OSHA, and hazardous waste-related issues.
Communicates and reports status of each project to the management and department that sponsors the project.
Maintains awareness of current pharmaceutical manufacturing needs and standards and initiates programs/projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site.
Directs and coordinates activities of various vendors for each project to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations.
Prepares URS, Risk Assessments, Safety Assessments associated with the project.
Oversees the execution of the project(s).
Develops and maintains Process Instructions for manufacturing equipment in accordance with site Change Control and Validation requirements.
Identifies and Implements process improvements.
Identifies and specifies process-specific equipment.
Troubleshoots, amends and accommodates the process of aseptic formulation and fill of drug product
Perform any other tasks/duties as assigned by Management.
BS in Engineering
5 years plant manufacturing experience.
5 years hands on experience with validated manufacturing process systems.
5 years of batch or continuous process system design and implementation.
Expertise in pharmaceutical instrumentation.
Process Control and Instrumentation experience.
Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design.
Working knowledge of AutoCad or SolidWorks.
Must be familiar with State, Federal and local codes.
Knowledge of Clean Room Classifications and process flow is a plus.
Project Management experience in a food, pharmaceutical or regulated environment preferred.
Experience with critical utilities (WFI, OFCA, Clean Steam, HVAC) is desired.
CIP/SIP experience is desired.
Six Sigma Training a plus.
Excellent verbal and written communications skills.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, and 401K with company match.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.
Website : http://www.fenwalinc.com
Fenwal is a pioneer and global leader in the development of products that improve the safety and availability of blood. Our products help shape the practice of transfusion medicine, making life-saving blood therapies available to the medical professionals and patients worldwide who rely on them.