Job Description
We are seeking a seasoned professional to lead our validation efforts, ensuring compliance with regulatory standards and internal quality policies. The ideal candidate will possess expertise in planning, coordination, and execution of validation activities.
The Validation Lead will be responsible for developing and implementing validation procedures, generating comprehensive reports, and supporting tender submissions by providing detailed validation documentation.
* Develop and manage validation plans, protocols (IQ, OQ, PQ), and reports in compliance with regulatory and industry standards.
* Lead validation efforts for HVAC equipment, facilities, lab equipment, and utilities systems.
* Collaborate with cross-functional teams to define and execute validation requirements.
* Maintain up-to-date knowledge of applicable regulations and ensure validation activities align with them.
* Identify and resolve validation-related issues, providing risk assessments and remediation plans as needed.
* Oversee the development and training of the validation team, ensuring high standards of competency and compliance.
* Provide technical validation support for tender processes, including preparing and reviewing validation documentation as part of bid submissions.
Required Skills and Qualifications
Relevant Engineering Qualification i.e., Level 7 or Level 8 Mechanical
* Minimum of 5 years working within a Lead role within a regulated environment
* Experience in a GMP manufacturing environment
* Proficient in the use of Microsoft office (excel, word, Power Point)
* Excellent communication skills, a confident and effective decision maker, with a proven ability to influence others
* Team player, with a flexible approach but also able to work under own initiative
Benefits
This role offers a unique opportunity to contribute to the growth and success of our organization, while also developing your skills and expertise in validation management.
Others
Full clean driving licence required. Must be eligible to work in Ireland.