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Cleaning Validation Engineer

  1. United States
Seattle
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
34851
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Cleaning Validation Engineer - Pharmaceuticals - Seattle - 12-Month Contract 

Our client, a global biotechnology organisation, is recruiting for a cleaning validation engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a Cleaning Validation Engineer to help expand our client's biotech operations throughout Europe. As the Cleaning Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


Role and Responsibilities:
  • Execute cleaning cycle development and PQ of equipment.
  • Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
  • Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
  • Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
  • Part-take in cross-functional problem-solving teams for troubleshooting and investigations.
  • Technical report writing, statistical analysis of data
  • Adherence to the latest regulatory guidelines.
  • Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
  • Adherence to highest standards for Compliance (Quality and Safety)
  • Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Requirements:
  • Experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
  • Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
  • A working knowledge of the GxP systems associated with this role would be advantageous.

If this role is of interest to you, please apply now! 

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