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Validation Specialist (Pharmaceutical Technology), Mayo
Client: TEAM HORIZON
Location: Mayo, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 106af21ba985
Job Views: 8
Posted: 28.04.2025
Expiry Date: 12.06.2025
Job Description:
Team Horizon is seeking an experienced Validation Engineer for the role of Pharmaceutical Technology Specialist for our Client based in Co. Mayo.
The successful candidate will be part of the Validation Department responsible for the qualification/validation of all CGMP equipment, systems, and processes. The role of the Pharmaceutical Technology Specialist is to ensure customer satisfaction is delivered with each revalidation, validation, and project work.
Why you should apply:
* This is an excellent opportunity to join a company recognized as a Great Place to Work in Ireland, with a solid employee-focused foundation.
What you will be doing:
* Oversee, coordinate, guide, and implement the site validation master plan under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. Ordering parts and equipment.
* Ensure that all validation requirements are met for any new process, equipment, or change to existing processes or equipment.
* Actively work on validation projects, being the departmental point person, and complete all associated project documentation in line with current corporate and regulatory expectations.
* Ensure that all documentation pertaining to each validation study under your 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. This involves review and approval of validation documentation and coordination of validation work.
* Facilitate the PQR review process, Regulatory Review Process, and Laboratory Equipment Review Process as per the current rota.
* Stay updated on current and changing regulatory guidance for the relevant validation areas.
* Provide support for audit preparation, participate in audits, and respond to audit findings.
* Support and comply with internal EHS requirements, procedures, and policies. Ensure continued conformance to EHS standards within the department.
* Achieve the company's quality objectives through continuous improvement and adherence to quality standards.
* Participate in Departmental and APEX meetings and engage in any Quality or Safety initiatives on site.
What you need to apply:
* A relevant 3rd Level Qualification is essential.
* Experience in Pharmaceuticals Manufacturing/Production is essential.
* Exceptional project management skills are essential. Proficiency in Microsoft Office suite is required.
* Experience with validation processes is essential. Excellent communication, organization, time-management, and teamwork skills.
* Ability to work independently with a results-driven mindset.
* Clear articulation when dealing with colleagues, peers, and managers.
* Ability to plan and schedule workload effectively.
* Capability to work under pressure and deliver results while overcoming obstacles.
* Occasional shift work may be involved.
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