Aseptic Operator III
Xellia

Cleveland, Ohio

This job has expired.


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 Operator III is part of Sterile Operations and is responsible for a variety of operations that support the aseptic filling processes at CLE site in Xellia. Aseptic Operator I performs a variety of operations that support the aseptic filling processes. These activities include both manual operations and interacting with highly automated equipment such as autoclaves, parts washers, formulations equipment and liquid fillers. This position is required to understand the equipment and adhere 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.

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Key Responsibilities

Technical Competencies

  • Complete all required training. Ensure that training is completed prior to performing any activity
  • Set-up, operate, and troubleshoot of key manufacturing equipment: including (but not limited to) autoclaves, parts washers, formulation equipment and liquid filler
  • Coordinate activities with team members for equipment operations
  • Assist in development and creation of departmental procedures including but not limited to SOPs, OJTs and Work Instructions
  • Performs On the Job Training of peers as well as supporting the development of new Trainers
  • Participate in investigations and execute appropriate approved corrective / preventative actions
  • Support the training of peers within the Sterile Operations department
  • Support the Shift Lead and Supervisor in the alignment and execution of shift activities
  • Serves as a Peer Leader for Xellia's Core Company Values both in words and actions
  • Coordinate and align between Sterile Operations and support departments on both routine and project related activities
  • Ensure that requirements for Environmental, Health, Safety (EHS) are met.
  • Documentation of perform 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 Co-workers

  • 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 of our 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
  • 5-10 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

Disclaimer

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


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