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Aseptic Operator I - 12 Hour Nights

Company: Xellia Pharmaceuticals USA, LLC
Location: Cleveland
Posted on: May 29, 2023

Job Description:

Position summary

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


                    • HS Diploma/GEDPreferred:

                      • 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 frequentbending 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.


                            This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Other duties and responsibilities assigned by management are considered incidental or secondary to the overall purpose of this job. Employees holding this position may be required to perform other job-related tasks as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
                            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

Keywords: Xellia Pharmaceuticals USA, LLC, Cleveland , Aseptic Operator I - 12 Hour Nights, Other , Cleveland, Ohio

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