Validation Engineer

Recruiter
Optimus Search Limited
Location
London (Greater)
Posted
08 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Are you a Validation Engineer interested in working for one of the UKs leading names in High-Tech Pharmaceutical Engineering? Are you looking for something new?! Then stop what you are doing and read on!Title: Validation EngineerRate: £70/hr +/-Location: LondonPositions Available: 3 EngineersType: Contract (12 Months Rolling)A Fantastic new role has just opened up at one of our leading Dublin based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.The proposed start date is March - We need YOUResponsibilities include: * Deputise in the absence of the QA Team Manager in relation to Validation activities. * Performs validation/qualification/calibration activities including equipment, facilities, systems, CSV, Labels and temperature controlled shippers in accordance with the QMS. * Performs change control activities relating to qualification/validation/calibration activities including writing and establishing protocols. * Executes IQ/OQ/PQ protocols, Conducts periodic reviews of all GMP IT systems, Supports QA in external audits, To maintain metrics on all validation/qualification and change control related tasks. * Ensures the validation/qualification schedule is maintained and reports are written on time and related documents are kept current. * To identify when timelines cannot be achieved and report to management/stakeholders. * Ensure that all equipment is appropriately labeled with the correct validation/qualification status and ensuring that failed/unsuitable equipment is removed from circulation. * Ensures that all reusable data loggers in use remain in a calibrated state, including responsibility for organising off-site calibrations as required. * Performs additional tasks as assigned by the QA Team Manager or that may be reasonably required to meet business needs. * Responsible for self-training on all current good practice and industry standard validation topics and procedures * To be available for infrequent overtime work as necessary and to be willing to attend site, out of hours, in the case of emergency or extraordinary work requirementRequirements * Educated to Bachelors degree or equivalent experience. * Experience in validation/qualification in a Pharmaceutical / GMP environment * Proven competence in Equipment Validation and Computer Systems Validation * Knowledge of conducting temperature mapping studies, including the operation of Kaye Data Loggers and equivalent * Working knowledge of regulatory requirements in the pharmaceutical industry. * A high degree of accuracy and attention to detail, with an organized methodical approach to achieving daily deadlines. * Ability to read and interpret general procedures and government regulations. * Ability to effectively present information and respond to questions from groups of managers, clients and inspectors * Ability to calculate figures and amounts such as proportions, percentages, area and volume * Proficient in personal computer skills; specifically Microsoft Office, Outlook and database managementIf you are interested please do not hesitate to email or call me!Shubert@optimussearch.com+44 20 30969 392

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