What are the responsibilities and job description for the Environmental Monitoring System Specialist position at Fagron?
About The Job
The Environmental Monitoring System (EMS) Specialist will be responsible for ensuring the effective operation and maintenance of the EMS system that monitors and controls cleanroom environments in the pharmaceutical manufacturing facility. This role is critical to ensuring compliance with regulatory standards, maintaining environmental conditions, and supporting continuous production operations within controlled environments.
Responsibilities
Profile/Experiences
Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.
The Environmental Monitoring System (EMS) Specialist will be responsible for ensuring the effective operation and maintenance of the EMS system that monitors and controls cleanroom environments in the pharmaceutical manufacturing facility. This role is critical to ensuring compliance with regulatory standards, maintaining environmental conditions, and supporting continuous production operations within controlled environments.
Responsibilities
- Oversee the monitoring of cleanroom parameters (temperature, humidity, pressure differentials, particulate counts, water specifications, etc.) through the EMS.
- Ensure that all building systems meet regulatory requirements, including cGMP, FDA, and ISO standards for cleanroom environments.
- Conduct regular checks of BMS data to ensure the proper functioning of all cleanroom equipment and systems.
- Respond to system alarms, investigating and troubleshooting any issues related to cleanroom conditions.
- Maintain accurate records of all BMS activities, including system performance logs, calibration, repairs, and any deviations.
- Generate and review reports on cleanroom environmental conditions, ensuring compliance with internal and external audits and regulatory bodies.
- Create and maintain SOPs for system monitoring, calibration, and maintenance procedures.
- Assist in maintaining water quality monitoring systems, including sensors, filtration systems, and any necessary corrective actions when deviations are detected.
- Ensure all water sampling activities comply with the standard operating procedures (SOPs) and regulatory requirements for pharmaceutical water systems.
- Assist in preparing for and participating in regulatory inspections and audits.
- Work closely with engineering and maintenance teams to provide support as needed and participate in problem solving and development initiatives.
- Support installation and commissioning of new cleanroom systems and EMS components.
- Troubleshoot system malfunctions, diagnose root causes, and implement appropriate solutions promptly.
- Collaborate with external vendors and contractors to resolve system-related issues.
- Collaborate with cross-functional teams, including quality assurance, engineering, and production, to optimize environmental conditions.
- Provide training and support to facility staff regarding the use and monitoring of BMS systems
Profile/Experiences
- Education: Degree in Engineering (Mechanical, Electrical, Control Systems, or related field) or equivalent experience.
- Experience: Minimum of 1-2 years of experience in environmental monitoring preferably within a pharmaceutical setting.
- Strong attention to detail and commitment to maintaining regulatory compliance.
- Excellent troubleshooting and problem-solving abilities.
- Good communication skills for effective collaboration across departments.
- Willingness to work flexible hours, including on-call support for emergency situations
Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.
