Environmental Monitoring Technician 2
GrifolsAbout the role
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Job Summary:
Responsible for collecting and accurately documenting environmental monitoring samples within manufacturing processing areas. This includes viable and non-viable air samples, surface samples, personnel monitoring, water samples, and clean compressed air, in accordance with the established schedule and procedures.
Essential Job Duties:
- Follow established procedures to perform routine monitoring throughout manufacturing processing areas, including viable air, non viable air, surface, personnel, water, and clean compressed air sampling.
- Follow established procedures for gowning when entering manufacturing areas, including Aseptic Processing Areas that require stricter gowning protocols and the use of an additional gown.
- Prepare supplies required for environmental monitoring and maintain inventory of supplies.
- Perform data review and SAP data entry.
- Will share general responsibilities for monitoring equipment maintenance and calibration, housekeeping, and other support functions.
- Support and closely interact with manufacturing and quality personnel in terms of all aspects relating to environmental monitoring.
- Strict adherence to established procedures and practices in compliance with FDA regulations, with a strong emphasis on accurate and thorough documentation in accordance with regulatory requirements.
- Adhere to departmental corporate safety policies.
- Trains entry level personnel as assigned based on proficiency. Performs more complex and advanced job tasks. Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
- Requires an in depth understanding of the fundamentals of microbiology, aseptic techniques and environmental monitoring.
- Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
- Ability to work independently with minimum supervision.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
- Must be proactive, results oriented, and have strong attention to detail.
- Self-starter with strong work ethic and the ability to exercise good judgment.
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
- Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
- Excellent verbal and written communication skills in the English language.
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Specific experience with LIMS (Laboratory Information Management System) is preferred.
Job Requirements:
- Associate degree in Microbiology, Biology or closely related scientific discipline is required. Bachelor's degree preferred.
- Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required.
- Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.
- Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
Occupational Work Demands:
Frequently sits for 1-2 hours per day. Stands for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Co
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