Aseptic Operator I - 8 Hour 2nd Shift
Xellia

Cleveland, Ohio

Posted in Pharmaceuticals


This job has expired.

Job Info


The Aseptic Operator I is part of Sterile Operations and is responsible for a variety of operations that support the aseptic filling processes at CLE site in Xellia. These activities include both manual operations and interacting with highly automated equipment such as autoclaves, parts washers, formulations equipment and liquid fillers. This position requires understanding of the equipment and adherence to the procedures that control operation of that equipment. These activities are performed in controlled environments were progressive levels of area sanitization and personal gowning are required. Operators follow Standard Operating Procedures (SOPs), Good Documentation Practices (GDocP) and current Good Manufacturing Practices (cGMPs).

A successful Operator understands and incorporates Xellia's Core Values as an essential part of their daily activities. Teamwork, Accountability, Integrity are highly desirable attributes. Xellia strives for all Associates to understand and appreciate who we are as an organization and the critical work that we perform in the manufacturing of life saving pharmaceuticals.

Key Responsibilities

Technical Competencies

  • Complete all required training. Ensure that training is completed prior to performing any activity
  • Set, operate, and troubleshoot key manufacturing equipment: including (but not limited to) autoclaves, parts washers, formulation equipment and liquid filler
  • Ensure that requirements for Environmental, Health, Safety (EHS) are met.
  • Documentation of performed tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) in a timely fashion
  • Ensure processes and products are in compliance with all local, state, and federal rules and regulations. 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. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.
  • 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.
  • Any other duties as directed by Production Management.

Core Company Values
  • Being our Best - "Bringing out the best in ourselves and others"
    • Working well both independently and as part of a team
    • Respectful interactions with others
    • Team success is highly valued

  • Accountability - "Accountability to Customers, Partners and Colleagues"
    • Perform work with a "Right 1st Time" mentality
    • Understanding and working to meet the needs of our Customers and Coworkers

  • Openness & Transparency - "Say what I do and do what I say"
    • Honest and trustworthy
    • Constructive and positive communications

  • Zest - "Our zest is what makes us unique"
    • Value the strength in diversity
    • Embrace change and continuous development
    • Value our purpose in working to save and enhance lives by leading the fight against infections

Requirements

Required:
  • HS Diploma/GED

Preferred:
  • Associates Degree
  • 0-3 years of related work experience in a cGMP environment / or cGMP trade certificate.
  • General computer skills proficiency
  • Military Service highly desirable

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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This job has expired.

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