Microbiology & Environmental Monitoring Specialist (m/f/i)
Job Description SummaryBD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Our location in Karlsruhe (Angiomed GmbH & Co.Medizintechnik KG) deals with the development and manufacture of minimally invasive products. Here we are looking for an Microbiology & Environmental Monitoring Specialist (m/f/i).
About the Role
The Microbiology & Environmental Monitoring Specialist (m/f/i) oversees and executes all microbiology and environmental control programs.
- Administration, execution and evaluation of the environmental monitoring program for Angiomed´s manufacturing areas (e.g., water total count, water endotoxin, surface microbial, air particulate, air viables, compressed air) to ensure an appropriately controlled environment within specified control limits.
- Administration, execution and evaluation of the microbiological monitoring programs for Angiomed’s product monitoring (bioburden and endotoxin monitoring).
- Responsible for the evaluation of test results, trend analysis and reporting of CAPA source data related to microbiology and environmental controls.
- Notification of affected departments on environmental and microbiological deviations. Manages and executes investigations to determine product impact and potential need for changes to environmental controls and product monitoring.
- Administration of testing programs conducted at external laboratories including provision of test protocols, test methods, sample size determination, delivery of samples to the laboratory and validations to ensure compliance to BD / Angiomed requirements.
- Responsible for change assessments / change controls regarding impact on microbiology / environmental controls and for performing BKU evaluations.
- Responsible for providing microbiological expertise during new product development, product modification studies and failure investigations regarding microbiological controls.
- Responsible for providing microbiological expertise regarding the hygiene program and training.
- Provides microbiological expertise to Angiomed facilities dept. regarding cleaning and contamination controls of the manufacturing areas.
- Support the sterilization program and related tasks as deputy for the person in charge
- Support the release of sterilization loads and product release per established procedures.
You have a Bachelor/Master/Diploma degree in Biotechnical Engineering, Chemical Engineering, Microbiology or similar.
Furthermore, you have:
- Fluent communication in German and English (oral and written).
- Preferably work experience in medical device industry or similar with good working knowledge of FDA/ISO/EN requirements as they relate to microbiology/environmental controls.
- Strong organizational and analytical skills.
- Proficient communication skills and technical writing in German and English.
- Strong computer skills and proficiency with software applications.
- Teamwork ability to interact effectively with internal and external customers.
Work environment: Job holder must be able to work in a team-oriented, fast paced environment. Good understanding of U.S. business culture and communication style.
- Collaboration in a highly motivated global environment.
- A familiar work climate in an innovative environment where your input counts.
- A safe workplace with long- term perspectives.
- We endeavor a long-term collaboration – hence corporate career planning throughout diverse phases of life conveys a high importance and value for us.
Angiomed GmbH & Co. Medizintechnik KG
Subsidiary of Becton, Dickinson & Co. (BD)
Primary Work LocationDEU Karlsruhe
Additional LocationsDEU Bruchsal
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