Environmental Monitoring Technician II
Xellia

Cleveland, Ohio

This job has expired.


The EM Technician II position works closely with other departments, such as Operations, Validations, Maintenance, Quality Systems, Product Release and Engineering to assure the support of the Environmental Monitoring department on various projects, studies and routine tasks. The individual holding the position of EM Technician shall be responsible for the timely completion of routine and project testing. This person will also be responsible for assisting in actions associated with environmental issues.

Key Responsibilities

  • Responsible for routine environmental monitoring samples in the classified areas (primarily but not limited to aseptic processing areas and classified manufacturing areas).
  • Performs the collection of utility samples and submits for testing.
  • Assists in the investigation of Environmental Excursions.
  • Evaluation and monitoring of personnel for Aseptic Behavior.
  • Performs evaluation of the classified areas with regards to fit and finish.
  • Obtain and maintain gown certification to include CNC, C/D and A/B areas.
  • Perform Aseptic Gowning certification sampling.
  • Prepare environmental monitoring plates and EM test reports for aseptic processing area.
  • 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.

REQUIREMENTS
  • High School Diploma required. Associates Degree in Applied Science preferred.
  • Ability to understand 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 desirable.
  • 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
  • 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).

Physical Requirements of the Role

Must be able to frequently stand, bend over, and walk around sterile environment. Occasionally crawling, climbing, reaching, crouching, kneeling, pushing and pulling. Repetitive motions with hands, arms, and legs, as well as frequently lift 10-25 lbs. Also must be able to carry 10-25 frequently. Fine manipulation of small instruments is required. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

#LI-AH1

#LI-Onsite

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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