Job Description
We are looking for a validation engineer to work as a member of the Operations Engineering/ Validation team. This is an initial 12-month contract to support the introduction of a new cleanline system. Strong validation skills are needed to develop and execute validation protocols. Applicants must have work authorization in place before applying to this role. . Essential Job Functions: Excellent organization, relationship building and influencing skills. Responsible for ensuring conformance with current equipment, process, and systems validation regulations. Management of the Asset Lifecycle for new equipment and processes (URS/RA/IQ/OQ/PQ). Assist in PFMEA studies and risk assessment effort for overall process. Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost). Knowledge of statistical analysis software (e.g. MATLAB) and manufacturing processes. Develop manufacturing process instructions and inspection specifications. Provide Training and Work instructions for production operators and inspectors. Carry out the validation of equipment and processes. Ensure adherence to regulatory requirements, ISO & FDA. * Education & Experience * Obtained as a minimum a Degree in Mechanical/Production/Manufacturing Engineering and 3 years minimum postgraduate (Ideally 5 years plus) experience in a medical device or comparable hi-tech environment. Cleanline validation experience desirable. Proven problem solving and hands on approach. A confident selfstarter with the ability to work on their own initiative or as part of a team. Technical skills: Proficient in the use of validation software packages and Minitab would be an advantage. Proficient in the use of drawing software(SolidWorks) Skills: Benefits