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The Coordinator of Environmental Monitoring (EM) at BDC Merck is responsible for overseeing and managing the environmental monitoring program to ensure compliance with regulatory standards and company policies. This role involves coordinating sampling activities Between BDC, Manufacturing and BMC, analyzing data, alert and action Limits. and ensuring that all environmental monitoring processes are executed efficiently and effectively.
Key Responsibilities:
- Collaborate on weekly schedule develop, implement, and maintain the environmental monitoring program in compliance with regulatory requirements and industry best practices.
- Coordinate all aspects of environmental monitoring, including air, water, and surface sampling.
- Coordinate all aspects of Utilities monitoring, including Gazes.
- Track and support the >deviation is Trackwise system.
- Implement CAPA and CCP Action
- Support activities related to Microorganism identification.
- Support planification activities,
- Participate in the EM committees and update the Microbiology lab Manager
Data Analysis and Reporting:
- Analyze environmental monitoring data to identify trends and deviations.
- Prepare and present reports on environmental monitoring results to management and relevant stakeholders.
- Ensure that all environmental monitoring activities comply with internal procedures.
- Collaborate with cross-functional teams, including Quality Assurance, Production, BMC, and Facilities, to ensure effective implementation of the EM program.
- Provide training and guidance to staff on environmental monitoring procedures and best practices.
- Identify opportunities for process improvements within the environmental monitoring program.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Microbiology, Environmental Science).
- Previous experience in environmental monitoring, quality assurance, or a related field, preferably in a pharmaceutical or biotechnology setting.
- Strong understanding of regulatory requirements related to environmental monitoring in classified area (e.g., FDA, EMA, ICH guidelines).
- Excellent analytical skills with the ability to interpret complex data.
- Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Proficient in the use of data analysis software.
- Experience with environmental monitoring in a cleanroom or controlled environment.
- Knowledge of laboratory practices and procedures.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!