The role of the EM Technician encompasses a range of crucial tasks in our manufacturing environment. These responsibilities include:
Gathering Environmental Monitoring (EM) samples from designated manufacturing areas, which encompass viable, non-viable, surface, personnel, TSB, and sterility testing, in accordance with the scheduled protocols.
Preparing the necessary equipment and supplies for environmental monitoring, along with contributing to general equipment maintenance, calibration, and housekeeping activities. This role also involves managing inventory, including consumables and reagents.
Comparing and inputting data into a computer database for the purpose of generating reports and identifying trends.
Conducting thorough reviews of test results against specified criteria to ensure quality and compliance.
Maintaining daily sample logs to ensure prompt testing and accurate tracking of all samples.
Managing and updating Instrument Usage and Calibration Logs based on instrument usage during sample preparation and testing.
Ensuring strict adherence to procedures and practices in compliance with FDA regulations, with a strong emphasis on meticulous documentation.
To be successful in this role, candidates should meet the following qualifications:
Possession of an AS/BS degree in microbiology, biology, or a closely related scientific field is required.
Preferably, a minimum of 1 year of relevant experience is preferred.
Experience in a pharmaceutical, GMP, or FDA-regulated environment is a significant advantage.
Basic understanding of microbiology, aseptic techniques, and environmental monitoring is essential.
Strong organizational, analytical, and problem-solving skills, enabling structured decision-making on a routine basis.
A proactive, results-oriented approach with keen attention to detail.
Self-starter with a strong work ethic and a demonstrated ability to exercise good judgment.
Capability to effectively prioritize and manage multiple tasks, meeting deadlines as required.
Strong interpersonal skills, allowing for effective interaction with individuals at all levels within a team-oriented environment.
Excellent verbal and written communication skills in the English language.
Proficiency in computer skills, particularly in MS Office applications (Outlook, Word, Excel, PowerPoint).