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. Ensure all validation requirements are met for any new process, equipment, or change to existing processes or equipment.
3. Actively work on validation projects, being the departmental point person, and complete all associated project documentation in line with current corporate and regulatory expectations.
4. Compile, authorize, and file all documentation pertaining to each validation study under his/her responsibility in a timely and organized fashion.
5. Work with other validation engineers to achieve compliance by coordinating each validation project assigned.
6. Ensure timely review of validation documentation and data generated within the team, ensuring all supporting data and packages are presented in the required format.
7. Keep abreast of current and changing regulatory guidelines for the relevant areas of validation that apply.
8. Provide support for audit preparation, direct audit interaction, and involvement in audit responses.
9. Participate in the risk assessment process for all business units and participate in the design review process 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. Participate in the site internal and external audit program (to include periodic review).
Requirements:
1. Bachelor’s Degree in a science-based or engineering discipline.
2. Minimum 5 years’ experience in the area of validation or a similar role.
3. Ability to articulate clearly when dealing with internal and external bodies.
4. Good written and oral communication skills and ability to communicate at all levels.
5. Expertise in relevant subject matter areas, e.g., Equipment Validation, Aseptics (Sterilization Validation), Vial Processing Line (Vial Washers, Deprogenation, Filling, Lyophilization, Isolator Technology), Facility Validation, Process Validation, Cleaning Validations, CSV, Automation, etc.
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