Commissioning & Qualification Engineer

Job type:
on-site
Start:
08/2015
Duration:
9 Months
From:
Real Staffing
Place:
England
Date:
07/08/2015
Country:
flag_no United Kingdom
project ID:
939481

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A company based in Manchester is seeking the services of a Validation/ Commissioning & Qualification Engineer on a initial 6 - 12 month contract. This role will be based at their site in Manchester as well as in Tradegar.

As one of the Validation/C&Q Engineers your key responsibilities will include: * Hands on Validation work specifically on the HVAC and Utilities Equipment on site

* Provide support to the project team for C&Q protocol generation / execution / coordination (FAT/SAT/IQ/OQ)

* In the context of investments projects (new or upgrades), ensure proper execution of the Company C&Q methodology and application of cGMP (Validation Master Plan, Design Qualification, Commissioning, Installation & Operational Qualification and Validation Reports)

* Review and ensure the compliance of the qualification protocols, review the commissioning and qualification raw data and finally approve the reports for conformance

* Ensure that all GMP aspects are respected during the project Required Profile Profile

* Have a scientific degree (Chemistry, Biochemistry, ...) or equivalent by experience

* Over 5 years' experience in C&Q in pharmaceutical area

* Good experience in managing qualifications projects

* Has an expertise in all commissioning / qualification aspects of new builds/refurbishments such as qualifications of HVAC systems, Clean Utilities (Clean Compressed Air, Clean Steam, Purified Water, Water For Injection, ...), autoclaves, CIP/SIP process, filling lines, and other equipment commonly used in vaccine manufacturing facilities and be able to manage most of these qualification aspects

* Good skills and competencies level in C&Q activities : organization, understanding and implementation of C&Q practices in projects, time schedule, team working

* Good expertise in GMP Practises (V cycle) The successful Validation Engineer will need to have had over 2 years Validation experience within a Pharmaceutical or GMP environment.

This role will also require excellent communication skills, team working and organisation skills as well as the ability to work independently.

If you would like further information on this role, or you would like to apply please reply with an updated CV and your expected hourly rate or you can contact me directly on