Project Manager, Digitalization

1. Plan, initiate, and execute digitalization/transformation projects, using principles of operational excellence to apply digital processes, while ensuring alignment with organizational goals and regulatory requirements. 2. Develop detailed project plans of small to medium complexity, including timelines, milestones, risk assessments, and resource allocation. 3. Monitor and manage project progress, identifying and resolving potential risks and issues. 4. Coordinate cross-functional teams, including IT, production, quality assurance, and regulatory affairs, to ensure seamless project execution. 5. Manage project budgets and ensure efficient utilization of resources. 6. Communicate project status, updates, and outcomes to stakeholders and senior management. 7. Foster collaboration and communication among stakeholders to align project deliverables with organizational goals. a. Provide specialized knowledge and expertise relevant to digitalization in the pharmaceutical sector, such as electronic batch records, automation, and compliance with regulatory standards (e.g., FDA, EMA). b. Act as a liaison between technical teams and operational staff to ensure the successful implementation of solutions that meet industry and organizational requirements. c.Ensure all projects adhere to pharmaceutical quality standards and regulatory guidelines. d. Conduct testing as needed to validate the success and compliance of implemented solutions. e. Provide training and knowledge transfer to team members and end-users on new systems,

processes, or technologies introduced through the projects. f. Provide First Level Support for troubleshooting (Incident Management) of the productive system. 8. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Manages, mentors and coaches 4 or more employees. Has hiring, firing and performance decision power

Manages, mentors and coaches less than 3 employees. Has hiring, firing and performance decision power

Manages, mentors and coaches other employees. Does NOT have hiring, firing and performance decision power

Does NOT manage other employees. Does NOT have hiring, firing and performance decision power

*Bachelor's/Master's degree in computer science, engineering or related field with at least 5 years of relevant experience. *At least 5+ years of experience working on relevant IT implementation projects. *At least 5+ years of experience in the production environment, desirable pharmaceutical industry/industrial engineering. *Proven experience as a Project Manager in the pharmaceutical or related industry. *Demonstrated expertise in digitalization initiatives, including experience with systems like MES (Manufacturing Execution Systems), LIMS (Laboratory Information Management Systems), or ERP. *Familiarity with pharmaceutical manufacturing processes, GMP regulations, and digital transformation strategies. *Understanding the concepts and principles of business process design with a focus on digitalization, Industry 4.0 *Knowledge in Computer System Validation (CSV) and Good Automated Manufacturing Practice (GAMP). *This position requires excellent problem solving and communication skills i.e. verbal, written and presentation. *Proven ability to work independently and in a team environment. *Demonstrated willingness to be flexible and adaptable to changing priorities and strong multi-tasking and organizational skills. *Excellent knowledge of English; Knowledge of German or other languages is an advantage.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

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, citizenship, immigration status, disabilities, or protected veteran status.