Cleaning Validation Engineer

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Salary Description:
Competitive Rates
Quanta Consultancy Services Ltd
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One of the top 10 best companies to work in Ireland is looking for a cleaning validation engineer for their large scale new facility north of Dublin. 

This is a great opportunity to join a Global biotech company for an initial contract until the end of the year.

There is lots of opportunities to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Standard Duties:

- Responsible for validating cleaning systems
- Equipment includes fixed & mobile vessels, Bioreactors, Transfer lines, UFDF skids etc
- Drafting & calculating Cleaning Verification & Cleaning Validation limits to ensure a robust cleaning validation programme
- Performing swab & rinse recovery studies
- Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, Validation Plans, and Policies, Procedures & Guidelines to ensure robust tested systems
- Assisting in audit preparation for internal, vendor and regulatory audits (e.g. HPRA and FDA)
- Support execution of all CQV deliverables; IOQ
- Generate and ensure timely approval of all Commissioning and IOQ Final Reports for systems

Standard Background:

- The ideal candidate should hold a minimum of a BSc qualification (Degree) in a scientific, technical or engineering discipline along with 2+ years of experience working with equipment in pharmaceutical manufacturing facilities
- A strong background in validation and biologics manufacturing is desired
- Knowledge of requirements for design, installation, Commissioning, Qualification and Validation of Biologics equipment, systems and utilities using risk-based approaches
- Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9)

For more information, please apply today!

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Contact Details:
Quanta Consultancy Services Ltd
Tel: (0) 1442 869 219
Contact: Alex Stanford

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