Validation engineer

Team Horizon is seeking a Validation Engineer Team Horizon for an 18 Month contract on behalf of our client, a leading Biopharmaceutical manufacturer in the West of Ireland. Why you should apply: * Opportunity to cooordinate the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met * Work with a diverse talented team on exciting projects What you will be doing: * Coordination / direction and active participation in the validation and qualification of site equipment, utilities, processes and software in compliance with policies, FDA, European cGMP and GAMP standards. * Generation of validation and qualification protocols and final reports to cGMP standards. * Generation of validation investigations and implementation of corrective actions. * Creation/Review/Approval of various qualification documents and test data. * Management of validation, exception event, and change control processes. * Maintenance and tracking of Engineering equipment, if applicable. * Completing all required training before executing a task. * Documenting all activities in line with cGMP requirements. * Updating of Engineering procedures, job instructions and forms to reflect current best practices. * Performing cross training within the team and training of new team members. * Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems. * Coordinating activities to maximize the effectiveness of all of the team members. * Maintaining the overall cGMP compliance of the engineering areas. * Communicating with peers and management regarding activities in the area, including elevation of events or concerns. * Required to work as part of cross functional internal and corporate teams. * Provide reports, schedules and timelines for qualification projects in progress to engineering manager. * Assign resources to qualification activities. * Liaise with vendors on system definition and design qualification. What you need to apply: * 3 years plus validation experience in medical device plastics processing, moulding or assembly operations. * A minimum of 3 years rsquo; experience in a cGMP regulated environment. * 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry. * 2 years plus of experience of validating in a highly automated environment. * Strong communication (written and oral), presentation and troubleshooting skills required. * Effective interpersonal and organizational skills. * Ability to work well both independently and in a team environment. * Capable of prioritizing work and multitasking