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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:
139
Posted:
21.01.2025
Expiry Date:
07.03.2025
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.
* 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 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, including the review and approval of validation documentation.
* 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 relevant to validation.
* Provide support for audit preparation, direct audit interaction, and involvement in audit response.
* Support and comply with internal EHS requirements, procedures, and policies to ensure continued conformance to EHS within the department.
* Achieve the company's stated quality objectives through continuous improvement efforts and conformance to quality standards.
* Attend Departmental and APEX meetings and actively participate in any Quality or Safety initiatives on site.
What you need to apply:
* Relevant 3rd Level Qualification is essential.
* Experience in Pharmaceuticals Manufacturing/Production is essential.
* Demonstrate exceptional project management skills and proficiency in Microsoft Office suite is essential.
* Experience with validation processes is essential. Excellent communication, organization, time-management, and teamwork skills.
* Demonstrate ability to work on one’s own initiative with a passion for results.
* Ability to articulate clearly when dealing with colleagues, peer groups, and managers.
* Ability to plan and schedule workload.
* Ability to work well under pressure and consistently deliver results while demonstrating an action-oriented approach to overcome obstacles.
* There may be occasional shift work involved.
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