Within B. Braun Melsungen AG, Hospital Care Division, we are looking for a CSV Engineer (f/m/d) to join the CSV Team within the Digital Process Development department at the earliest possible date.
A key component of the required validation activities is ensuring the implementation of high-quality automation systems throughout project phases by planning, executing, and documenting validation activities during commissioning at the respective sites. The focus of this role is not only on fulfilling all internal requirements for these systems but also on ensuring compliance with applicable regulatory requirements, standards, and guidelines. Essential aspects of the position include maintaining, optimizing, and further developing validation activities both within the department and across projects.
Responsibilities
- Responsible for ensuring a compliant workflow for the regulated qualification and validation of computerized systems.
- Actively contribute specialist expertise and experience to the further development of B. Braun validation guidelines and support the creation of SOPs.
- Participate in the preparation of user requirements specifications (URS) and process descriptions.
- Develop and create qualification and validation plans (DQ, IQ, OQ, PQ, PV), risk assessments, and execution guidelines for qualification and validation testing of software systems, equipment, and processes, while coordinating with the relevant stakeholders.
- Responsible for qualification environments throughout all phases of the system lifecycle.
- Plan, support, and execute all CSV activities within qualification environments and during site rollouts in collaboration with local teams.
- Support and execute all activities related to Data Integrity.
- Coordinate qualification and validation activities, evaluate and statistically analyze measurement results and other raw data, and prepare validation reports.
- Collect, monitor, review, and ensure the archiving of qualification and validation plans, reports, and associated raw data.
- Initiate and coordinate corrective actions arising from qualification and validation activities.
- Work closely with various departments, including Project Teams, Quality Unit, IT, and Engineering.
- Inform management of significant events and project progress through established reporting procedures, particularly in exceptional situations or in cases of significant deviations from defined objectives and requirements.
Professional Qualifications
- Successfully completed vocational training, dual-study program, or university degree in a scientific discipline, pharmaceutical engineering, process engineering, or a comparable field.
- Several years of professional experience in Computerized Systems Validation (CSV), preferably within the pharmaceutical industry.
- Good written and spoken English skills, as well as solid IT skills (MS Office).
- Strong teamwork skills, confident professional presence, and excellent communication abilities.
- Independent, structured, and solution-oriented working style.
Personal Competencies
- Enjoy collaborating with others to achieve ideas and objectives.
- Strive for solutions that create value for all stakeholders.
- Organize and prioritize tasks in line with business objectives.
- Accurately assess opportunities and risks and understand cause-and-effect relationships.
- Willingness to travel and flexibility.
Benefits
- Employee networks
- Company pension scheme
- Mobility benefits, such as the B. Braun Job Ticket and Job Bike
- Work-life integration offerings, such as holiday childcare programs
- Flexible working arrangements, including flextime and home office options
- Employee discounts
B. Braun Melsungen AG | Dennis Friedrich