Cleaning Validation Engineer

2 days ago


Sligo, Ireland Team Horizon Full time

Team Horizon is seeking a Cleaning Validation Engineer for our Clients manufacturing facility in Sligo. In this role you will execute cleaning validation tests in accordance with approved protocols, procedures and guidelines.Why you should apply: * You will provide technical leadership in the area of cleaning validation and own the cleaning validation strategy for the site. * Join a company and team who strive to have a remarkable impact on people's lives across several key therapeutic areas.What you will be doing: * Design, plan and execute cleaning and process validation activities in accordance with regulations and guidelines. * Create and the implementation of the cleaning validation strategy * Analyze data and provide recommendations for improvements in cleaning / manufacturing processes * Provide technical leadership for deviation investigations related to cleaning validation activities (residual product/detergent and microbial contamination issues). * Write technical cleaning evaluations as requested, including calculations, and deviations with root cause and impact assessment. * Generate the closure and validation report for cleaning validation of various equipment systems * To coordinate the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met. * Generation/maintenance/execution of the Site Validation Master Plan. * Generation/maintenance/execution of Project Validation Plans and schedules. * Generation of validation protocols and final reports to cGMP standards. * Creation/Review/Approval of various quality documents and test data. * Management of validation, exception event, and change control processes. * Maintenance and tracking of validation equipment, if applicable. * Completing all required training before executing a task. * Documenting all activities in line with cGMP requirements. * 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 production areas. * Communicating with peers and management regarding activities in the area, including elevation of events or concerns.What you need to apply: * Qualification and/or degree in engineering or scientific discipline. * 3 years plus of knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry in a sterile environment. * Strong communication (written and oral), presentation and troubleshooting skills required * Ability to work well both independently and in a team environment. * Capable of prioritizing work and multitasking



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