Validation Engineer - Pharmaceutical Processing & …, Southampton

Our Client is a well-established expert in the pharmaceutical, nutraceutical, biopharmaceutical and biotechnology processing and manufacturing industries. They are now seeking a Validation Engineer. This position will be based near Southampton, Hampshire. The position is a full-time permanent role. Job Purpose * To manage the design and production of all validation processes and qualification documentation packages for both in-house and external site related testing and qualification activities in accordance with the Company?s Quality Management Procedures Key Responsibilities * To be familiar with, and act in accordance with, all relevant health and safety management legislation * To be familiar with, act in accordance with, and help develop the company quality systems rules, regulations and policies * Works within corporate policies and frameworks, but also encouraged to influence directions taken on strategic issues * To follow GAMP principles as appropriate, ensuring validation methods are consistent with the approach and that quality is built into each stage of the processes * To provide comprehensive support in the issue, administration and control of all qualification related documents and the associated reference drawings and specifications * To ensure all qualification documents including reference documents are completed, signed off and archived as appropriate before release of originals for execution to customers, both at FAT and the SAT (IQ / OQ) phase * To conduct and assist the Project Team in the execution of Factory Acceptance Testing with or without customer attendance * To liaise and consult with the in house commissioning team to ensure understanding of protocol execution procedure is understood * To work in collaboration with all related departments to ensure delivery of protocols on time to project requirements * To develop and communicate a clear option structure to allow Sales to offer appropriate Qualification and Validation packages, understanding the full implications of each option. In turn ensuring that the day-to-day business is set-up appropriately to manage and execute projects in line with these requirements * To read Technical input documentation & Design Drawings such as Process & Instrumentation Diagrams (P&ID), Arrangement Drawings (GA), System Loops Drawings (SLD) in order to create customer specific protocols * To routinely employ key performance indicators to monitor efficiency and effectiveness, whilst ensuring quality, and schedule adherence in key areas of the role * To ensure the qualification documentation is produced is in line with the expectations of the industry and continuously strive to improve the content and quality using different (appropriate) communication methods, techniques and tools as required * Must look to other sites and other industries to benchmark existing documents allowing us to identify and implement improvements as expected by ourselves and our customers * To co-operate with other Sites in order to achieve appropriate synergies. * To assist in all related test and qualification activities where appropriate to provide assistance and to aid the on-going improvement of our documentation systems * To provide administrative support for all documents in the qualification scope * To maintain accuracy of all data within the respective IT systems pursuant to their activity Qualifications and Experience * Degree in Engineering or any related technological science, preferably in the field of process engineering * GAMP/GDP qualification * Lean Six Sigma Training is preferable * Experience in Validation Systems * Experience of Change Control procedures * Experience in developing & managing documentation processes * Knowledge of Pharmaceutical qualification procedures * Ability to work across all departments to develop department improvements * Ability to lead on Validation matters as necessary * Basic knowledge essential of engineering software programs i.e. IFS, SAP In return, our Client is offering a basic salary of £40,000- £45,000 per annum plus benefits (Salary is negotiable and dependent on experience). To apply for the above position, please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd