Our client based in Westport are looking to hire a Validation Engineer for an exciting new project.
Responsibilities: Oversee, coordinate, guide, and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner.To ensure all validation requirements are met for any new process, equipment, or change to existing processes or equipment.To actively work on validation projects, being the departmental point person, and completing all associated project documentation in line with current corporate and regulatory expectations.To ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorized, and filed in a timely and organized fashion.To work with the other validation engineers to achieve compliance by coordinating each validation project assigned.Ensure timely review of validation documentation and data generated within the team & ensuring all supporting data and packages are presented in the required format.Keep abreast of current and changing regulatory guidelines for the relevant areas of validation that apply.Provide support for audit preparation, direct audit interaction, and involvement in audit responses.Participate in the risk assessment process for all business units & participate in the design review process for all business units.Support and comply with internal EHS requirements, procedures, and policies.Achieve the company's stated quality objectives through continuous improvement efforts and conformance to quality standards.Attend Departmental and OPEX meetings and participate in Quality and Safety Initiatives.Provide support for audit preparation, direct audit interaction, and involvement in audit response.Participation in site internal and external audit program (to include periodic review).Requirements: Bachelor's Degree in a science-based or engineering discipline.Minimum 5 years' experience in the area of validation/similar role.Ability to articulate clearly when dealing with internal and external bodies.Excellent conflict handling skills.Good written and oral communication skills and ability to communicate to all levels.Excellent problem-solving skills, time management & project management skills.Expertise in the relevant subject matter areas – example Equipment Validation, Aseptics (Sterilization Validation), Vial Processing Line (Vial Washers, Depyrogenation, Filling, Lyophilization, Isolator Technology), Facility Validation, Process Validation, Cleaning Validations, CSV, Automation etc.For more information or a confidential discussion about this role, please contact Michelle McInerney.
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