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CQV Engineer (Autoclave & Parts Washer), Sligo



Sligo, Ireland 

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Job Description:

The Opportunity

Team Horizon have an opportunity for a CQV Engineer (Autoclave & Parts Washer). The successful candidate is required for the qualification of process and ancillary equipment (IQ/OQ/PQ), qualification of sterilization processes including autoclaves, depyrogenation and steam in place (SIP) systems, facility qualification (controlled environments), critical utility qualification, cleaning validation, computer validation, process validation and/or requalification.

The Role

  • Support the process of Technical Transfer of products to site
  • Responsible for developing and executing commissioning and qualification documentation for new or modified process systems and equipment. This may include the development of user and function requirements, execution of factory/site acceptance testing, commissioning, and development of design qualifications
  • Serves as of contact for validation studies performed by external contractors or vendors, coordinating execution of studies with our clients Manufacturing Operations, Engineering, Utilities and QA personnel as required.
  • Support continuous improvement of our client’s facilities and equipment by risk assessing proposed changes to ensure the qualified state is maintained. Generate and execute approved change control test scripts to demonstrate that proposed changes are appropriate and do not impact equipment or process validation.
  • Maintain specialist validation equipment in a compliant state, ensuring that raw data is archived appropriately in a GMP compliant data storage system.

The Person

  • Bachelor’s Degree in engineering or scientific discipline preferred. Associate’s degree or certificate in biotechnology (minimum) required.
  • Direct experience performing validation studies in cGMP biopharmaceutical or aseptic filling environment is required. Knowledge of aseptic processing and liquid filling operations preferred.
  • Must be able to analyse data using basic statistical methods.
  • The incumbent should possess knowledge of cGMP requirements for biopharmaceutical manufacturing and / or aseptic processing including aseptic liquid filling.

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Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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