Sterile Operations Co-Op (Spring 2023)

Cleveland, Ohio

Posted in Pharmaceuticals

This job has expired.

Job Info

We are seeking an Sterile Operations Co-op who will help us with all necessary tasks both in and outside of the classified manufacturing suites in support of manufacture of safe and effective sterile (injectable) pharmaceutical products at the Xellia Cleveland plant.

Key Responsibilities

  • Applies general engineering theories, principles and knowledge to process and facility design, testing, quality, safety, and aseptic production activities.
  • Perform job functions within compliance of 21CFR part 210 and 211, FDA, OSHA and other regulatory agencies.
  • Ensure that the current requirements for Environmental, Health, Safety (EHS) issues are met within the production operations.
  • Set-up, Operation, and troubleshooting of key manufacturing equipment: including (but not limited to) lyophilizer, autoclave, parts washers, filler, capper, CIP/SIP skid, etc.
  • Documentation of perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) in a timely manner.
  • Assist in the execution of equipment/process qualification, validation, and protocols as required.
  • Assist in development and creation of departmental procedures to include but not limited to SOPs, OJTs, and work instruction documents
  • Participate in investigations, and execute appropriate approved corrective / preventative actions for Aseptic Core related processes.
  • Read, comprehend and execute Standard Operating Procedures (SOP) and instruction documents.
  • Demonstrates ability to read, comprehend and interpret equipment manuals, P&ID's, mechanical and electrical drawings.
  • Partners with Quality to ensure processes and products comply with all local, state, and federal rules and regulations.
  • Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing and personal protective equipment appropriate for the duties they perform

Experience and Skills

  • Currently enrolled in an accredited engineering undergraduate or graduate program (mechanical, chemical, bio-medical, etc.)
  • Strong Academic Performance
  • Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA, EPA and other regulatory agencies.
  • Interest in pursuing a career in the Pharmaceutical Industry

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

This job has expired.

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