Our client based in Westport are seeking a highly skilled Validation Engineer to lead an exciting new project.
The role offers both permanent and fixed-term opportunities.
Key Responsibilities:
* Develop and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner.
* Evaluate and ensure all validation requirements are met for any new process, equipment, or change to existing processes or equipment.
* Lead validation projects as the departmental point person, completing associated project documentation in line with current corporate and regulatory expectations.
* Ensure timely compilation, authorization, and filing of all documentation pertaining to each validation study.
* Collaborate with other validation engineers to achieve compliance by coordinating assigned validation projects.
* Review validation documentation and data generated within the team, ensuring presentation in the required format.
* Stay up-to-date with current and changing regulatory guidelines for relevant areas of validation.
* Support audit preparation, direct audit interaction, and involvement in audit responses.
* Participate in risk assessment processes for all business units and design review processes.
* Adhere to internal EHS requirements, procedures, and policies.
* Achieve 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 responses.
* Contribute to site internal and external audit programs (including periodic reviews).
Requirements:
* Bachelor's Degree in a science-based or engineering discipline.
* Minimum 5 years' experience in validation or a similar role.
* Excellent communication skills when dealing with internal and external bodies.
* Strong conflict handling skills.
* Effective written and oral communication skills, with ability to communicate at all levels.
* Superior problem-solving skills, time management, and project management skills.
* Expertise in relevant subject matter areas, such as Equipment Validation, Aseptics, Vial Processing Line, Facility Validation, Process Validation, Cleaning Validations, CSV, and Automation.