Validation Engineer
Abbott
Donegal, Connaught/Ulster
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150+ countries and employs approximately 97,000 people. In Ireland, Abbott has five business units, represented across eight manufacturing sites. The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system. We are seeking a validation /cleanroom engineer with experience in qualifying clean rooms, HVAC systems and associated monitoring activities. In this role reporting to the Technical Manager you will be part of a team responsible for developing the cleanroom qualification strategy, execution and subsequent monitoring, which will facilitate the introduction of new equipment into the area. Job Specification: Experience with custom URS, FS, Installation, Operation and Performance Qualification protocols for equipment including HVAC and cleanroom facilities, purified water systems, compressed air and gas systems, autoclaves, ovens, and other controlled environment equipment (preferably in a medical device or pharmaceutical environment. Knowledge of production cleanrooms including HEPA integrity testing and ISO 14644 particle count certifications, preferably with experience in ISO 8 Cleanrooms. Prepare GMP compliant test reports & ability to understand technical drawings and manuals. Ability to extract technical requirements from various sources and create executable protocols from the technical requirements. Create & lead complex project plans, managing the associated cost and time constraints. Support the development and validation of new equipment, processes and materials. Support the development and execution of engineering trials / characterisation studies. Contribute to the design of technical design specifications , SOPs, protocols, specifications and validation documentation (IQ/OQ/PQ) to meet regulatory requirements. Summarise, analyse and draw conclusions from test results leading to effective technical resolution. Qualifications. Science or engineering degree with minimum of 3 year’s experience. Experience in the development, support &, improvement of production systems in a manufacturing environment. Experience in the development & qualification of manufacturing equipment or manufacturing materials. Excellent communication / interpersonal skills. Enthusiastic and energetic with the ability to integrate quickly into a team environment. Demonstrated flexible and innovative approach to work. This job originally appeared on RecruitIreland.com.
2041 days ago