Validation Engineer - 6 Month Contract - Urgent

I have an urgent requirement for a Qualification Engineer to join a leading Generics organisation based in the Yorkshire for a 6 month contract. The role exists to provide qualification engineering support to project teams and the ongoing maintenance of qualification standards and documentation at a site level.

Academic Background and Experience:

*Educated to graduate level in Engineering or Science subjects
*Experience of pharmaceutical manufacture to appropriate standards of Safety & cGMP.
*Experience of risk assessment and risk based decision making
*Working knowledge of projects and key qualification requirements to standards & guides e.g. ICH Q7, ISPE Guides, GAMP, Orange guide, CFR 21, etc
*Experience of working cross functionally and in multidisciplinary teams
*Experience of execution of qualification protocols & documentation systems

Job responsibilities:

1.Ability to interpret European/US cGMP Guidelines/Regulations with respect to qualification and apply them to current work practices maximizing the value of the qualification activities.
2.Integrate the requirements of HSE legislation to ensure compliance through the cycle of qualification; DQ, IQ, OQ & PQ - maximizing the value of the qualification activities.
3.Implementation of, and adherence to DRL/CTO qualification standards working directly with colleagues in CTO Projects
4.Plan qualification activities both at a project and site level
5.Provide expertise and support on qualification activities and documentation to project teams (both DRL & Third Party) adopting data based decisions e.g. statistically and capability based.
6.Maintain qualification documentation; Data sheets, URS and protocols for ongoing use and provision of 'turnover packages'.
7.Participate in multifunctional projects leading the qualification element in line with project goals
8.Manage small projects
9.Works with DRL personnel/contracts to coordinate qualification activities as part of major projects
10.Maintain qualification registers/data bases for URS, Data sheets, CSV systems
11.Author qualification documentation and lead periodic qualification reviews and initiatives
12.Ensure qualification activities trigger appropriate site systems such as maintenance, written schemes, calibration etc
13.Adopt a continuous improvement philosophy with respect to documentation and execution of protocols to eliminate waste & duplicate activities

Key performance Indicators:

1.Compliance with all cGMP and HSE regulatory requirements of qualification
2.Completion of qualification documentation and tracking completions in data base or concerto
3.Adherence to qualification and project plans

Key skill and personal attributes:
*Ability to contribute to effective team output by cooperation, participation and commitment to shared goals.
*Project management skills
*Self motivated with the ability to work independently and under pressure
*Ability to build relationships with other functions and team working
*Problem solving skills
*Competency with standard software e.g. Microsoft Office
*Ability to interpret and critically assess technical data
*Meticulous attention to detail

This role requires someone who can start within the next few weeks, and interviews will commence tomorrow! This is an exciting opportunity which may potentiall lead to a permanent position should the candidate see fit.

If you are interested please contact Hemish Ilangaratne on 020 7758 7322 or email with an updated CV immediately.

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