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Manager - Microbiological & Hygiene Rep.
Are you passionate to be in the role as a Microbiological and Hygiene Representative Manager ? Do you have experience in contamination control, cleanroom environmental oversight, and microbiological quality assurance
? This role plays a critical part in supporting patient safety, product sterility, and regulatory compliance. If so, this opportunity could be for you! Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated.
Take the next step in your career with us and help shape the future of healthcare!
As a Microbiological and Hygiene Representative Manager at B. Braun you will play a vital role in…
Your key responsibilities:
- Implement and maintain contamination management strategy considering regulatory requirements.
- Ensure compliance with regulatory standards and internal quality requirements by managing cleanroom environmental controls, microbiological quality, and product hygiene processes.
- Set up cross-functional team to define relevant monitoring points in cleanroom.
- Manage the procedures for controlling and monitoring the cleanroom environments and product microbiological quality.
- Oversee routine monitoring activities to ensure cleanroom operations comply with specifications and regulatory standards.
- Lead the review and analysis of trend data for environmental and microbiological monitoring, including airborne particles, surface hygiene, temperature, humidity, differential pressure, product sterility, bioburden, and endotoxin results.
- Coordinate with the validation team to plan and manage cleanroom qualification and requalification programs.
- Drive cross-functional investigations and resolution of out-of-specification issues, ensuring effective CAPA implementation.
- Participate as third party investigator in microbiological deviation investigation events.
- Manage risk assessment processes related to cleanroom environments and their impact on product sterility and patient safety.
- Supervise the compilation, maintenance, and archiving of all environmental and microbiological monitoring records.
- Support and participate in internal and external audits relevant to the cleanroom environments and product microbiological quality.
- Support patient safety and product sterility through proactive monitoring, risk assessment, and cross-functional collaboration.
- Maintain robust documentation and audit readiness for cleanroom and hygiene-related processes.
- Provide technical guidance and training to Production on cleanroom practices.
- Support continuous improvement initiatives to enhance environmental control and product sterility assurance.
- Subject Matter Expert for microbiological topic:
- Central interface for microbiological and production-related hygiene in the manufacturing
- Professional evaluation and independent analysis of existing specification documents (e.g., Change Control, Deviation Handling)
- The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
- Bachelor’s or Master’s degree in Microbiology, Biotechnology, Pharmaceutical Science, or related field.
- Minimum of 5–8 years’ experience in pharmaceutical, medical device, or sterile manufacturing environments.
- In‑depth knowledge of ISO 13485.
- In-depth knowledge of ISO 14644.
- In‑depth knowledge of ISO 17141 for requirements and methodologies for controlling microbiological contamination in cleanrooms and controlled environments.
- In‑depth knowledge of ISO 14971 principles for medical device risk assessment and mitigation
- Strong experience with cleanroom environmental monitoring and contamination control programs.
- Strong understanding of sterility assurance, environmental monitoring methodologies, and microbiological risk assessments.
- Experience in deviation investigations, root cause analysis, and CAPA management.
- Strong analytical and problem‑solving abilities.
- Excellent communication and cross-functional leadership.
- Detail-oriented with strong documentation and audit readiness mindset.
