VALIDATION ENGINEER- 6 Month contract- Westport The Validation Department is responsible for the qualification/validation of all CGMP equipment, systems, and processes utilized for routine operation. The Department is also responsible for the revalidation of critical systems & processes. The role of the Validation Engineer is to ensure customer satisfaction is delivered with each revalidation, validation, and project work. All validation activity is to be performed in line with Global Standards, FDA, HPRA, and other MPH regulatory requirements. This schedule compliance will be achieved by actively engaging with senior management and the impacted BUs and ensuring all projects can be managed and prioritized as required. Responsibilities:Oversee, coordinate, guide, and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. Ensure that all validation requirements are met for any new process, equipment, or change to existing process or equipment.Actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations. Ensure that all documentation pertaining to each validation study under his/her responsibility is compiled, authorized, and filed in a timely and organized fashion. Work with other validation engineers to achieve compliance by coordinating each validation project assigned. The process involves the review and approval of validation documentation and coordination of the validation work.Participate in risk assessment process for all business units & participate in design review process for all business units.Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire, etc.).Facilitate the PQR review process/Regulatory Review Process and Laboratory Equipment Review Process as per the current rotas.Keep abreast of current and changing regulatory guidance for the relevant areas of validation that apply. Provide support for audit preparation, direct audit interaction, and involvement in audit response.Support and comply with internal EHS requirements, procedures, and policies. Ensure continued conformance to the EMS within the department. Achieve the company's stated quality objective through continuous improvement efforts and conformance to quality standards. Attend department and APEX meetings and participate in Quality and Safety initiatives.Provide support for audit preparation, direct audit interaction, and involvement in audit response. Participate in site internal and external audit program (to include periodic review).Qualifications:Bachelor's degree required in a science-based or engineering discipline.Experience in a Pharmaceutical company.Excellent project management skills.Proficient in the use of Microsoft Office suite of programs.Critical thinking and problem-solving skills.Ability to articulate clearly when dealing with internal and external bodies.Excellent conflict handling skills.Expertise in the relevant subject matter areas – examples include Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning.
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