Validation Process Engineer

Employer
Location
Cork
Salary
Neg
Posted
Nov 09, 2017
Closes
Dec 18, 2017
Ref
959508726
Contract Type
Full Time
Job Type
Engineer
Are you a Validation Process Engineer interested in working for one of the world leading names in High-Tech Pharmaceutical Equipment Engineering? Are you looking for something new?! Then stop what you are doing and read on! Title: Validation Process Engineer Rate: Negotiable Location: Cork - Ireland Type: Contract (12-18 Months) A Fantastic new role has just opened up at one of our leading Cork 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 January 2018 - We need YOU Responsibilities include: * To support all validation actively, developing and refining equipment and systems. * Support the Department in maintaining a validated process and validated equipment. * The support includes managing process improvement projects, problem solving for manufacturing issues, and support of key site processes. * Ensuring the site Validation Master Plan is updated and completed annually. * Ensuring the Process Plan is updated and completed annually. * Carryout the Site Periodic Review, which involves ensuring that each department reviews their system and reports on the quality and validation status of their system. * Carryout validation and annual qualification on the following types of equipment; * WFI (Water for Injection), Compress Air, HVAC (Heating Ventilation & Air Conditioning) and Cleanroom classifications, LAF (Laminar Air Flow) and Smoke Studies, Vial Washers, Filling Machines, Cleaning validation on Process Vessels, Product Transfer Lines & parts, Warehouse Thermal Mapping, Production/Packaging processes * Trending of quality metrics to identify area of improvement. * Ensuring all engineering systems operate as per validated process and ensuring all routine validation is completed on time. * Write and execute all validation life cycle documentation all the way through from requirement specifications to test documentation to validation reports. * Implementation of a risk based approach to validation ensuring compliance of system. * Computer System Validation and ensuring 21CFR11 compliance. * Identify opportunities to implement process improvements and lean practices in all parts of the plant including Business Unit (Production and Packaging), Utilities, and Warehouse. * On-going systems development in terms of Safety, Quality, Productivity, Output, Cost, and Yield. Requirements * Engineering or Science Honours Degree. * At least 5 years' experience in validation within a GMP approved pharmaceutical or process industry with specific experience in batch preparation, filling environments, and clean utilities. * Good knowledge of and experience with Process Validation, Technical Documentation, Engineering Standards, and Guidelines. * Experience in working in a GMP regulated environment. * Good knowledge of Eudralex, European Pharmacopeia, GAMP5, FDA standards, Computer System Validation, and current validation regulatory requirements. * Excellent written and oral communications skills and the ability to deal with a variety of people on a wide range of tasks. * Must be good record keeper and results analyser. If you are interested please do not hesitate to email or call me! [Email address removed] [Phone number removed]