The Aseptic Production Operator I position is responsible for the operation of various types of processing and test equipment in aseptic areas, using excellent aseptic practices and behaviors, per Standard Operating Procedures. This includes but is not limited to: steam sterilizers, filling equipment, performing interventions, transfer carts, and capping equipment and other associated equipment. As part of these responsibilities, the Aseptic Production Operator I monitors operations, completes and/or reviews data to ensure requirements have been met and completes all associated documentation.
Aseptic Production Operator levels are differentiated based on the ability to perform tasks in various areas independently and with a high level of proficiency and knowledge of the area and equipment.
Complies with cGMP through adherence to SOP's, Master Batch Record Instructions, and company policies with a focus on quality and safety to produce parenteral products that improve the public health. Ensure training is in compliance with job role before performing any activities in the production operation.
Ensures that the equipment is cleaned and maintained properly and the work areas are clean and maintained as required. This requires sanitization of walls, ceilings and floors as well as counter tops and tables. Clear and clean production lines as required before and after all operations.
Responsible for reviewing raw cycle data to ensure process standards are met. Analytical reasoning ability and an understanding of the principles of cGMP production are required to accurately assess compliance to cycle standards.
Exercises sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product.
Communicates with Production management, Quality Assurance, Quality Control, Maintenance and Engineering staff pertaining to status of manufacturing operations, including but not limited to: equipment reliability, environmental problems, and potential quality and compliance concerns.
Monitors manufacturing cycles. Verify and document production activities both manually and on computer systems, including batch records, log books, etc. to ensure requirements of production have been met.
Responsible for maintaining a safe work environment and reporting any potentially hazardous conditions to supervisor.
Setup and adjust equipment as required for proper operation, including disassembly and installation of all equipment and parts required for product runs. Operate a variety of production equipment, as mentioned above, to support production operations.
Receive, check, store, handle and deliver bulk and finished drug products as required or directed. Utilize appropriate material handling equipment in accordance with standard operating safety policies.
Assists in ensuring that schedule efficiency, product quality, regulatory, safety and financial goals are met.
Meet attendance requirements for the job.
Maintain proper hygiene as required by cGMP's.
Participate on working teams, as applicable.
Obtain and maintain aseptic gowning qualification.
Assists departments and performs other duties as specified by the Production Supervisor.
Education & Experience
High school diploma or equivalent
Knowledge of cGMP's and ability to apply analytical reasoning and root cause analysis to solve problems.
Basic math and science skills and ability to use a computer.
Demonstrated ability to read, understand, interpret and apply technical writing and instruction.
Strong communication skills: both verbal and written.
Related work experience in a regulated environment, preferred.
Strong mechanical aptitude and root cause analysis, preferred.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.