CIP CQV Engineer -Pharmaceutical

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.

The candidate must have the rights to work in the location stated in the job advert.

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