The Validation Manager is responsible for managing Validation personnel at Melrose Park facility. The individual will oversee validation activities related to equipment and computerized system qualifications and re qualifications. Responsibilities Manage a team of Principal, Senior and entry level Validation Engineers whose responsibility is to perform qualification, re q

The Analyst, Contract Marketing and Commercial Analysis extracts, analyzes, and interprets data from an array of systems to address complex business issues. The Analyst also prepares and summarizes commercial and customer analysis to identify key trends and communicates business drivers, market dynamics, competitive landscapes, and product/therapy opportunities to marketi

The position is responsible for maintenance, compliance and change control of the electronic batch records generated through the PAS X system. In this capacity, Electronic Batch Record Designer is responsible for creating Electronic Batch Record templates and Product Batch records for the Melrose Park manufacturing site. Responsibilities Assures timely generation of execu

We currently have an opportunity for a Summer 2024 Intern to join our Manufacturing Engineering team at our Grand Island, NY facility. Responsibilities Interact with personnel on all levels in Production. Collect data on existing challenges, perform analysis, and determine best possible course of action to address them. Look for ways to standardize tasks in order to reduc

We currently have an opportunity for a Summer 2024 Manufacturing Engineering Intern to join the Team at our Grand Island, NY facility. Responsibilities Interact with personnel on all levels in Production. Collect data on existing challenges, perform analysis, and determine best possible course of action to address them. Look for ways to standardize tasks in order to reduc

The Director, Quality Assurance will manage quality projects, lead Continuous Improvement initiatives, and will drive change to further integrate and implement Ivenix Infusion System into the Fresenius Kabi organization and systems. A key aspect will be to ensure compliance with the U.S. regulatory requirements and FDA expectations are met. This will be in close cooperati

POSITION SUMMARY Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas. Responsibilities

The Engineering Specialist (Hardware) will perform mechanical engineering, technical project management and provide guidance/leadership responsibilities in the hardware development team. Lead activities by driving, planning, directing and implementing designs and improvements to the mechanical systems in Fresenius Kabi infusion devices to achieve product performance goals

We hire you at an Entry Level and you advance by demonstrating growing skill levels of operating and maintaining production equipment. Within one year, you will be able to fully operate state of the art equipment through advanced HMI interfaces. For those individuals with Team Leader/Supervisor experience, we offer opportunities to become a technical expert and lead our o

Responsible for Electrical Engineering tasks within a sustaining engineering role function, specifically in a manufacturing environment. Apply specialized knowledge to manage and complete complex projects, including design and/or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generates and implements i

Perform standard Mechanical Engineering tasks within a sustaining Engineering role function, specifically in a manufacturing environment. Select appropriate techniques to solve problems and make design recommendations under direction of Supervisor. Assess results for application, validity, and conformance to specifications. Utilize engineering tools to solve technical pro

Perform standard Mechanical Engineering tasks within a sustaining Engineering role function, specifically in a manufacturing environment. Select appropriate techniques to solve problems and make design recommendations under direction of Supervisor. Assess results for application, validity, and conformance to specifications. Utilize engineering tools to solve technical pro

Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off line inspection area and therefore must be knowledgeable of procedures and equipment in each area. Responsibilities Visually inspec

The Engineering Specialist, DevOps plans, directs, implements, and maintains the North Andover Business Unit (NABU) hardware and software infrastructure in order to enable the delivery of Fresenius Kabi products. This position acts as technical leader for the DevOps team and may be responsible for mentoring junior staff. Responsibilities The Engineering Specialist, DevOps

This position will be responsible for Supplier Quality in the Production Unit (PU). This position will ensure compliance to quality system requirements and drive the highest quality standards by helping to define specifications and by collaborating with suppliers. This role requires working in a cross functional team environment with members of the R&D Design Centers, for