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.
What you will bring to the team:
- 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 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.
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Strong understanding of sterility assurance, environmental monitoring methodologies, and microbiological risk assessments.
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Experience in deviation investigations, root cause analysis, and CAPA management.
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Strong analytical and problem‑solving abilities.
- Excellent communication and cross-functional leadership.
- Detail-oriented with strong documentation and audit readiness mindset.
What sets B. Braun apart?
Founded in Germany in 1839, B. Braun is a leading medical technology company with over 66,000 employees in 64 countries. Specializing in infusion therapy, orthopaedics, neurosurgery, anaesthesia, and more, B. Braun develops high-quality products and services that improve global health. In Asia Pacific, B. Braun employs over 16,000 people across 10 production sites and 16 business offices.
Established in 1972, B. Braun Medical Industries in Penang is the regional headquarters for APAC. With more than 7,000 employees, the plant located in Penang is among the largest manufacturers of medical, surgical and pharmaceutical products not only in Malaysia but also in the APAC region. It also houses the Centre of Excellence for Intravenous Access.
What can we offer you?
- Retirement benefit scheme
- Long service award
- Medical insurance
- Training and development programs
- Education assistance program
What’s next?
Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the interview. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary!
We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.
To find out more about our commitment to diversity click here
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B. Braun Medical Ind. Sdn. Bhd. | Nur Fathoonna Yahya | nur_fathoonna.yahya@bbraun.com