Aseptic Operator II - Night Shift - 12 Hours
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Would you like to join an award winning organization that is dedicated to saving lives?
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.
Is that you? If so, we want to learn more about you!
Our Bedford, OH facility is seeking an Aseptic Operator II who performs a variety of operations that support the aseptic filling process, primarily the highly automated capping, compounding, vial wash, and filter integrity testing equipment. This operator’s duties may include at a minimum the ability to complete all responsibilities of an Aseptic Operator I plus equipment set-up before production run, and room and equipment reset between batches. An Aseptic Operator II holds a significant understanding of the equipment and procedures and may be expected to support the training of co-workers.
Key Responsibilities
- All key responsibilities of an Aseptic Operator I
- Safe setup and operation of filter integrity testing equipment
- Safe setup, cleaning, sterilization, and operation of the compounding equipment
- Safe setup, loading, unloading, cleaning, and operation of vial washers
- Safe setup, loading, unloading, cleaning, and operation of the vial capper
- Cleaning and disinfection of Grade C and D 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
- 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.
- Safely operates equipment and troubleshoots problems to ensure process parameters are met throughout the run.
- Any other duties as directed by Production Management.
Experience and Skills
Required:
- HS Diploma/GED
Preferred:
- Associates Degree
- 3-5 years of related work experience in a cGMP enviornment/or cGMP trade certificate
- General computer skills profiency
- Military service highly desirable
- Demonstrated proces/equipment troubleshooting
We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!
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
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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