Validation Engineer - Medical Devices

We are looking for an experienced manufacturing engineer to support equipment installation & Validation (IQ/OQ/PQ) and Vendors management.

Tasks:

. Provide direction and technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation.
. Support new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
. Develop process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
. Participate in and leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development and other sites.
. Act as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.

Requirements:

. Experience in manufacturing and/or engineering is required.
. Previous experience working in Medical Device or Life Science sector is required.
. Experience with either with packaging, Laser, Cleaning or CNC processes and equipment, required
. Six Sigma or Lean Sigma certification or 4 years of experience preferred.
. Experience developing and implementing robust automated manufacturing equipment, preferred.

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.