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