Our client based in Westport are seeking a highly skilled Validation Engineer to lead an exciting new project.
Both permanent and fixed-term opportunities are available for this challenging role.
Key Responsibilities:
* Develop, implement, and oversee the site validation master plan under prospective, concurrent, and retrospective validation studies.
* Evaluate and ensure all validation requirements are met for new processes, equipment, or changes to existing ones.
* Lead validation projects, serving as the departmental point person, and complete associated project documentation according to current corporate and regulatory standards.
* Organize and maintain timely documentation for each validation study, ensuring authorization and filing in a structured fashion.
* Collaborate with other validation engineers to achieve compliance by coordinating assigned validation projects.
* Review and verify validation documentation and data generated within the team, presenting supporting data and packages in the required format.
* Stay up-to-date with changing regulatory guidelines relevant to validation.
* Provide support for audit preparation, direct audit interaction, and involvement in audit responses.
* Participate in risk assessment and design review processes across various business units.
* Adhere to internal EHS requirements, procedures, and policies.
* Contribute to achieving quality objectives through continuous improvement efforts and adherence to quality standards.
* Attend departmental meetings, participate in quality and safety initiatives, and provide support for audit preparation and response.
* Participate in internal and external audit programs, including periodic reviews.
Requirements:
* Bachelor's degree in a science-based or engineering discipline.
* A minimum of 5 years' experience in validation or a similar role.
* Effective communication skills when dealing with internal and external stakeholders.
* Excellent conflict resolution and problem-solving skills.
* Strong written and oral communication skills, with the ability to communicate at all levels.
* Expertise in relevant subject matter areas, including Equipment Validation, Aseptics, Vial Processing Line, Facility Validation, Process Validation, Cleaning Validations, CSV, and Automation.