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CIP CQV Engineer -Pharmaceutical

  1. East
  1. Contract
Competitive
26190WP
  1. Commisions, Qualification and Validation
Date Posted02 Feb 2021

This vacancy has now expired

CIP CQV Engineer - 12 month contract - Biopharmaceutical

Large-scale greenfield Biotechnology have a contract requirement for an experienced CIP CQV Engineer to support the commissioning & qualification activities for several CIP skids.

Manufacturing biological bulk drug substance products, you will provide expertise to support the start-up into routine commercial manufacturing.

You will be accountable for the timely completion of all CIP-related commissioning and qualification.

Key Responsibilities: 
  • Manage, coordinate, and guide CIP CQV execution based upon the validation plan.
  • Serve as a subject-matter expert on CIP Skid, routes, and circuit related activities.
  • Author & review commissioning and qualification documents such as IOC/Q protocols,  qualification  validation protocols, summary reports risk assessments and deviations.
  • Owns the closure of any open issues such as SAT punches & deviations.
  • Trouble shoot CIP-process and skid-related issues.
  • Identify and implement CIP related improvements where feasible.
  • Assist in the development and optimization cleaning CIP cycles/recipes for media, buffer, upstream and downstream equipment trains.
  • Supports system handover to Manufacturing.
  • Demonstrates proficiency in communicating and collaborating with stakeholders and vendors.
  • Participates in internal and external audits when required.
  • Temporary shift work may be required as needed.

Qualifications & Experience
  • B.Eng or B.Sc in Chemical / Process engineering or relevant science discipline is required.
  • A minimum of 2-5 years’ experience for CIP CQV engineer, candidates with 5+ years’ experience may be considered for a Senior CIP CQV engineer role.
  • Knowledge and experience with facility start-up projects (brown field or green field).
  • Experienced in the execution of commissioning and qualification of CIP skids and associated process equipment (e.g., process vessels, etc).
  • Possess in-depth knowledge of CIP skid operation & CIP loop tuning & CIP cycle development.
  • Possess in depth knowledge of hazards associated with CIP skid start up
  • Experience in troubleshooting and providing technical and engineering solutions for CIP-based perations and equipment in a biologics or similar processing environment.
  • Experience in automation change control.
  • Good interpersonal skills coupled with demonstrated ability to effectively work with cross functional area.
Call me to discuss this role in further detail.

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