Aseptic Operator III
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København
Production
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.
Qualifications:
- HS Diploma/GED and 5-7 years applicable experience is required
- Bachelor of Science or Engineering Degree, preferred
- Military experience is desirable
- Demonstarted process/equipment troubleshooting
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.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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Information og data
Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Laborant
- København
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