Description
Our client, a world Leading pharmaceutical company are seeking a number of Project Engineers/ Work Package Managers to lead the design, installation and procurement of a number of pieces of Oral Solid Dosage equipment on a major new build OSD facility.Based from the UK predominantly this role will involve regular travel to supplier and client sites in Russia and Germany
This is a major CAPEX and is scheduled to run until December 2015.
Initial contract duration will be 12 months with scope for extension until project completion.
• Key Accountabilities
• Deliver the scope of the technical work packages to the schedule, cost and performance requirements
• Agreed with the Project Manager, Technical Lead including expediting delivery from the suppliers.
• Ensure the compilation of the Work Package estimates and schedules to meet the project targets agreed with the Project Manager.
• Establish appropriate measures to monitor the delivery of the Work Packages to meet project targets.
• Ensure appropriate and sufficient internal and external resources are available to deliver the Work Packages to project targets.
• Ensure the proper installation, commissioning and qualification (DQ, QP, IQ, OQ) of the Work Package.
• Liaise with User team Supplier to finalise residual design issues and agree scope of FAT,SAT,IQ,OQ protocols
• Accountable for driving delivery schedule from procurement through qualification including completion of FAT,SAT,IQ OQ testing
• Ensure the Work Package technical performance criteria are met.
• Close engagement and coaching and influencing with User team
• Coordination and Leadership of Factory test events test events with Supplier & User
• Validation Support Accountabilities
• Be experienced in delivery and qualification of Pharma process equipment on international capital projects.
• Ideally be familiar with risk based qualification approaches
• Coached and technical directed by Validation team.
• Working closely with Work package owner and Equipment supplier and User team and Subject matter experts to deliver GMP compliant Process Equipment/Critical utility systems
• Ensure that all GMP and Computer validation aspects identified in the Qualification plan are adequately incorporated into validation activities
• Attend all test events FAT.SAT,IQ,OQ and ensure good test practice in line with GMP expectation
• Develop effective and close engagement with user team, specifically the QA function to ensure alignment of expectation, agreed test protocols and issue resolution to enable seamless acceptance of validation testing schedule the 4 FTE Validation support personnel
Requirements
• Language skills Project language is English but German or Russian language skills would be an advantage
• Experience of delivering full equipment installation lifecycle including full commissioning and qualification in a pharmaceutical oral solid dose environment
• Candidates will provide evidence of WPO or Validation Support knowledge and experience with track record or successful delivery on international projects
• Knowledge of granulators, tablet presses, tablet coaters, fluid bed driers.
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Please apply now highlighting your equipment experience and knowledge of working internationally providing full package delivery.
Excellent rates are on offer along with the opportunity to work on a benchmark, high profile international project.