Aseptic Operator III - Night Shift - 8 Hours
Xellia

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In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment.

We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.

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Position Summary

Aseptic Operator III performs a variety of operations that support aseptic filling process, primarily the highly automated fill equipment inside an aseptic environment. This operator's duties may include at a minimum the ability to complete all responsibilities of an Aseptic Operator I and Aseptic Operator II, plus the filling line, HEPA carts, lyophilizers, and capper discharge equipment. This operator must have the demonstrated skills and reliability to operate in cleanroom Grade A and B spaces, in an aseptic manner, to support open vial filling operations. An Aseptic Operator III holds a significant understanding of the aseptic equipment and procedures, is able to lead junior operator in performing unit operations, and can be relied upon to train co-workers.

Key Responsibilities

• All Key responsibilities of an Aseptic Operator I
• All Key responsibilities of an Aseptic Operator II
• Safe setup, cleaning, and operation of the vial filling line
• Safe setup, cleaning, and operation of the HEPA carts that transfer vials from the filling line to the lyophilizers
• Safe setup, cleaning, and operation of the lyophilizers
• Safe setup, cleaning, and operation of the capper discharge module (CDM)
• Cleaning and disinfection of Grade A and B spaces and equipment
• Perform job functions while maintaining compliance with 21CFR part 210 and 211, FDA, OSHA, and other regulatory agencies.
• Ensure that requirements for Environmental, Health, Safety (EHS) are met.
• Complete all required training. Ensure that training is completed prior to performing any activity
• Follows proper aseptic gowning requirements while ensuring compliance with environmental monitoring procedures.
• Documents all work accurately and in a timely manner. Self-monitors and reviews all documentation for completeness and accuracy. Reconciles components and product ensuring batch accountability.
• Any other duties as directed by Production management.

Requirements

• Required:
  • HS Diploma/GED and 5-7 years of applicable experience

• Preferred:
  • Bachelor of Science or Engineering Degree.
  • Military service is highly desirable.
  • Demonstrated process/equipment troubleshooting preferred.

Physical Requirements of the Role

• Candidate must be capable of extended periods of standing and movement with frequent bending and lifting up to 40lbs.
• Candidate must obtain and maintain appropriate gown qualifications.
• Candidate will be required to wear PPE (Personal Protective Equipment), including respirators.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
• Candidate will not be permitted to wear (in the classified manufacturing areas) jewelry, makeup, hair extension, or any exterior adornment (religious articles will be evaluated on a case-by-case basis as to assess impact on controlled environment and drug product).
• All personnel shall be required to disclose any health conditions that may have an adverse effect on drug products.
• Candidate will be required to work overtime as required.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

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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.
Read more about Xellia Pharmaceuticals here

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