Search the 19 jobs at Fresenius Kabi

The Sr Compliance Specialist in R&D is responsible for ensuring compliance with internal SOPs, company policies, and cGMP requirements in the Research and Development department. They review stability summaries, method validation reports, cGMP protocols, controlled documents, and assist in audits and investigations. The role also involves representing Quality in project teams, performing internal audits, and supporting regulatory inspections.

The Medical Device Quality Management System (QMS) Project Manager is responsible for planning, executing, and overseeing projects related to the development, enhancement, and maintenance of the Quality Management System (QMS) in compliance with regulatory standards. This role requires strong project management skills to ensure that QMS initiatives are completed on time, within scope, and in alignment with organizational objectives. The QMS Project Manager will work closely with cross-functional teams, including quality assurance, regulatory affairs, product development, and manufacturing, to drive continuous improvement in quality processes and ensure regulatory compliance.

The Strategy Project Manager will lead development of strategic initiatives to improve the efficiency and growth ambitions of the generics business, manage multidisciplinary teams, deliver financial analysis, define project scopes, resolve risks, lead change management, and ensure compliance with company standards.

Oversee document management and training for medical device design, development, and manufacturing processes. Develop and maintain document management system, create training programs, ensure regulatory compliance, lead team collaboration, and drive continuous improvement initiatives.

Managing implementation of projects related to the manufacturing of terminal sterilized pharmaceutical bags, providing process analysis, executing process improvement ideas, managing process improvement projects, and supporting operations and quality teams.

The Associate Technical Writer is responsible for investigating deviations, customer complaints, and writing documents. Responsibilities include implementing change controls, cost improvement initiatives, and new product introductions. Requires a Bachelor's degree, advanced critical thinking, and 1-2 years of experience in GMP manufacturing environment. Familiarity with FDA regulatory requirements is necessary. Excellent salary and benefits are offered.

Analyzing and executing processes to ensure product quality in the Production Unit. Providing Quality support for product development initiatives and manufacturing operations. Initiating and managing CAPA records. Supporting internal and external audits. Compiling and analyzing quality metrics. Ensuring regulatory compliance and upholding the Quality Management System. Collaborating with cross-functional teams on daily tasks and projects.

Responsible for operating and troubleshooting high-speed IV bag filling line, conducting in-process control testing, and promoting teamwork through communication. Must have 3+ years of pharmaceutical experience and be adept at problem-solving in a clean room environment.

Experienced software solution architect with a background in Pharma, Bio-Tech, or Medical Device industries. Responsibilities include interpreting business requirements, architecting solutions, providing technical assessments, and working with internal teams and software vendors. Requires 5+ years of experience in API, Web Service, third-party integrations, and Life Sciences business processes. Proficiency in Apriso MES, ERP (SAP), Azure DevOps, JIRA, confluence, and Azure cloud environments. Familiarity with Agile Methodology.

The Full Stack Senior Software Engineer will enhance web application user interfaces, services, and data model while influencing the current product and developing the next generation. Responsibilities include technical leadership, code reviews, resolving software defects, and mentoring junior staff. Requirements include a Bachelor's degree in Computer Science with 8-10 years of experience, Agile environment experience, software product development experience, and proficiency in C# and related technologies.

The Systems Administrator is responsible for providing IT support for local R&D and enterprise systems, managing Windows and Linux environments, troubleshooting IT issues, and collaborating with the R&D team on specialized IT systems.

The Software Systems Engineer will be responsible for system design, integration, and maintenance of data management products. They will collaborate with cross-functional teams, lead technical projects, and ensure compliance with regulations. Experience in Agile, cybersecurity, and system design is required.

The Supply Chain Analyst provides comprehensive data analytics and administrative support to the Distribution Center leadership, coordinating with interdepartmental leadership to ensure cohesive analytics requirements across departments. Analyzes data and processes to manage the distribution center network effectively.

The HR & Training Generalist provides staffing, training, and general HR support for exempt and non-exempt employees in the assigned Market Unit Distribution Center. Responsibilities include employee relations support, recruitment, onboarding, training delivery, and data entry into the Learning Management System.

The Senior Analyst, Contract Marketing and Commercial Analysis is responsible for managing contracting activities for GPOs, IDNs, tiered agreements, and complex key accounts in the IV Therapy business. This individual collaborates with various teams to address complex business issues and improve overall team efficiency.

Responsible for driving ISO Systems and Sustainability programs, optimizing organizational performance, creating and executing ISO Systems strategy, guiding cross-functional teams, training employees, conducting process analyses, leading ISO projects, monitoring performance, promoting innovation, and ensuring compliance with health, safety, and quality standards.

The Technology Transfer Scientist is responsible for assisting with the transfer and implementation of new processes for Biosimilar drug products into the plant manufacturing site. They support project teams, prepare manufacturing sites, provide technical assessments, and execute necessary studies to maintain product life cycles and manufacturing processes.

This entry-level position involves providing Service Depot process development support for the Iventix system. Responsibilities include developing, designing, and implementing processes and procedures to support the LVP Service Depot, collaborating with cross-functional teams, and contributing to projects for quality improvements and cost savings. The role also involves research, analysis, and ensuring compliance with company standards.

Aseptic Control Operators are responsible for cleaning, setup, operation, and maintenance of production lines while following strict procedures and regulations. Additional tasks include unloading ovens, routine cleaning, and minor maintenance. High school diploma and mechanical aptitude are required.