Grifols Shared Services North America, Inc Aseptic Filling Core Technician I/II/III in Clayton, North Carolina
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Performs a variety of operations involving the support of aseptic filling of plasma products, primarily operation of highly automated fill equipment inside the aseptic environment. Major duties will include operation of the fill/stoppering equipment to dispense sterile product into glass containers, calibration of critical loadcells before, during and after each fill, environmental monitoring of the aseptic environment during each fill, loading and unloading of sterile products from freeze dryers, and operation of the continuous particulate monitoring system during each fill. The responsibilities include the monitoring and troubleshooting of the fill process through the use of computer terminals and electronic trends and data to ensure proper functioning of the equipment. Responsibilities also include high levels of mechanical aptitude during setup and troubleshooting of the equipment. Trouble-shooting may include adjustment of photo-optic sensors and mechanical adjustments to the fill line. Predominant activities will include: high levels of housekeeping to conform to cGMP standards, cleaning and sanitizing aseptic filling areas to maintain the quality of the product, assembling and disassembling of equipment before and after use, and performing operations during fills by following proper procedures. Position will also be required to operate of all fill line equipment outside of the aseptic filling environment such as vial rinsers, depyrogenation tunnel, oversealers, cage loaders, cage rinsers, etc. Job responsibilities also include detailed and accurate documentation in batch production records. Must be able to determine availability of components and assign accordingly. May also be required to assist in training of co-workers. Must be able to perform in the aseptic filling areas while maintaining the integrity and cleanliness of these areas by utilizing aseptic gowning requirements and techniques.
One year of pharmaceutical , chemical and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC) obtained within the last 5 years OR
Graduation from an accredited college/university with an Associate’s or Bachelor’s degree in: Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum OR
Completion of the Bioworks Certification Program
SALARY GRADE: N4 / N6 / N7
SHIFT: 12 Hour Rotating
Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals and to electrical manufacturing equipment and moving machinery. Exposure to high levels of noise. Occasional entry into confined spaces, requiring kneeling and squatting. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Work is performed sitting for 4-6 hours per day. Occasionally walks, stands and bends waist for 2-4 hours per day. Repetitive hand movement of one hand with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying of 15-44lbs. for 1-2 hours per day with a maximum lift of 50lbs. May reach above and below shoulder height. Hearing acuity essential. Color perception/discrimination, far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs simple and repetitive tasks that vary little each day by following a set of written or oral instructions/procedures.
Learn more about Grifols at http://www.grifols.com/es/web/international/home