Job Description
Our client based in Westport is looking to hire a Validation Engineer for an exciting new project.
There are permanent and fixed-term opportunities available.
Responsibilities:
1. Oversee, coordinate, guide, and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner.
2. Evaluate all validation requirements for any new process, equipment, or change to existing processes or equipment.
3. Work on validation projects as the departmental point person and complete all associated project documentation in line with current corporate and regulatory expectations.
4. Ensure that all documentation pertaining to each validation study under your responsibility is compiled, authorized, and filed in a timely and organized fashion.
5. Coordinate with other validation engineers to achieve compliance by assigning and managing validation projects.
6. Review validation documentation and data generated within the team and ensure that all supporting data and packages are presented in the required format.
7. Stay up-to-date with current and changing regulatory guidelines for relevant areas of validation.
8. Support audit preparation, direct audit interaction, and involvement in audit responses.
9. Participate in risk assessment processes for all business units and participate in design review processes for all business units.
10. Support and comply with internal EHS requirements, procedures, and policies.
11. Achieve the company's stated quality objectives through continuous improvement efforts and conformance to quality standards.
12. Attend Departmental and OPEX meetings and participate in Quality and Safety Initiatives.
13. Support audit preparation, direct audit interaction, and involvement in audit responses.
14. Participate in 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 the area of validation or a 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, and project management skills.
* Expertise in relevant subject matter areas, such as Equipment Validation, Aseptics (Sterilization Validation), Vial Processing Line (Vial Washers, Deprogenation, Filling, Lyophilization, Isolator Technology), Facility Validation, Process Validation, Cleaning Validations, CSV, Automation, etc.