Job Description

Overview
Manage and perform the installation of extensions to existing validated data acquisition systems in Harlow and Ware. The candidate must be capable of managing small projects and working to agreed timescales.
The candidate will be expected to liaise between client contacts (users, QA, validation) and system integrators during each project and will take responsibility for each project document deliverable (see responsibilities below.)
A full set of template documents have been developed and the candidate will be expected to use these for the creation of all project deliverables.
Responsibilities
Specific tasks will include:
 Creation of User Requirement Specifications, FAT and Validation Reports.
 Raise the appropriate change control documentation.
 Review of vendor supplied design documentation (FDS, HDS, SDS), FAT and IQ/OQ protocols.
 Witnessing of FATs at system integrator sites (UK.)
 Execution of IQ/OQ testwork on-site in Harlow and Ware.
The candidate will report progress to the BLL project manager.
Skills
 Knowledge of automation systems particularly SCADA, PLCs and data historians.
 Specific knowledge of Siemens PCS7/WinCC and AspenTech IP.21 an advantage but not essential.
 Solid experience of computer validation according to a GAMP 4 lifecycle.
 Experienced in test execution, documenting results and managing test failures to GMP standards.
Location
The role will be based in Harlow, Essex with possible occasional travel to/from Ware in Hertfordshire (approximately 20 minutes drive from Harlow.)

Qualifications/Skills Required

Computer Validation Engineer