Environmental Monitoring Specialist I - Days
Xellia

Job Info

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!

Position Summary

The Aseptic Environmental Monitoring Specialist I position works closely with other departments, such as Operations, Maintenance, Quality Assurance, Validation, and Engineering to assure the support of the Environmental Monitoring department on various projects, studies, and routine tasks.

The individual holding the position of Environmental Monitoring Specialist I shall be responsible forperforming routine and non-routine testing. They will be responsible for Environmental Monitoringdocumentation and corrections. The individual will assist with the training of environmental monitoringpersonnel on tests and methods.

Key Responsibilities

• Responsible for routine environmental monitoring samples in the classified areas (primarily but

not limited to aseptic processing areas and classified manufacturing areas).

• Obtain and maintain gown certification to include CNC, C/D and A/B areas

• Required to maintain Media Fill qualification

• Performs environmental monitoring during active filling operations

• Assist with Environmental Excursion investigations

• Evaluation and monitoring of personnel for Aseptic Behavior

• Perform Aseptic Gowning certification sampling.

• Performs evaluation of the classified areas with regards to fit and finish.

• Assists with revision of standard operating procedures.

• Assists with training new department personnel.

• Assists with execution of validation test support.

• Assists with the execution of equipment and method validation.

• Reviews data generated by EM technicians and approves testing paperwork.

• Assists with the training of EM and production personnel on proper aseptic technique, behaviors,

setup and operation of equipment.

• Follow safety requirements and maintains good housekeeping of work areas.

• Assumes additional duties and responsibilities as assigned.

• 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.

• Oversee that processes are in cGMP compliance, and establish systems that identifies

opportunities for improvement and makes constructive suggestions for change to improve

process effectiveness to heighten quality.

Requirements

• Bachelor's Degree in Microbiology/Science or related field

• 1-5 years related experience

• Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211,

cGMP's, FDA, OSHA and other regulatory agencies.

• Experience in the pharmaceutical industry in regards to Aseptic/Injectable processes preferred

• Read, comprehend and execute Standard Operating Procedures (SOP) and instruction

documents.

• Work effectively wearing all required clean clothing and PPE such as head, face, hand and arm

coverings to include goggles and full body suits.

• Work with minimal supervision and escalate potential issue when necessary.

• Assist other colleagues where needed.

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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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