Eirdata Head of Validation

Cork

9 months ago

Applications closed

Who we are:
Established in 2001, Eirdata are specialists in cleanroom validation, commissioning & compliance. We provide these range of services to the pharmaceutical, medical devices and healthcare sectors primarily. In 2013, Eirdata was acquired by ESS Ltd. Engineering, Support & Services (ESS) Ltd We work with our people to implement and carry out maintenance and asset management to optimise performance.
ESS Group includes three companies – Engineering Support & Services Ltd. (ESS), Eirdata Environmental Services Ltd. (Eirdata), and the newly joined Critical Airflow Europe (CAE).

ESS are experts in asset management and maintenance reliability through people.
Eirdata are specialists in cleanroom validation, commissioning and compliance, HVAC systems, indoor air quality and building wellness.
CAE are the European leader in delivering safe energy efficient laboratory control and critical airflow applications. Critical Airflow Europe Ltd represents Phoenix, Strobic.

Position Overview:
The Validation Lead is responsible for overseeing the planning, coordination, and execution of validation activities within the organization. This includes ensuring compliance with regulatory standards, internal quality policies, and project requirements. The role also involves the development and implementation of validation procedures, generating comprehensive reports, and supporting tender submissions by providing detailed validation documentation. The Validation Lead will play a key role in offering technical validation support across projects, managing follow-ups to ensure timely closure of validation activities, and driving process improvements to enhance operational efficiency and compliance. Additionally, the role supports the development and growth of the business, working closely with the General Manager, Operations Manager, and HVAC Services Lead to achieve strategic objectives.

Responsibilities:
Develop, manage, and execute 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 client cross-functional teams (e.g., Quality Assurance, Engineering, Manufacturing) to define and execute validation requirements.
Maintain up-to-date knowledge of applicable regulations (e.g., FDA, EU GMP, ISO 14644) 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.
Conduct annual reviews for the team.
Provide technical validation support for tender processes, including preparing and reviewing validation documentation as part of bid submissions.
Conduct validation follow-ups to ensure all identified actions and non-conformances are closed in a timely and compliant manner.
Create and refine validation procedures to align with regulatory and internal standards, ensuring repeatability and efficiency.
Manage validation project timelines, budgets, and resources effectively.
Drive continuous improvement initiatives within validation processes to enhance efficiency and compliance.
Act as the primary point of contact for internal and external audits concerning validation activities.
Ensure company validation, calibration and maintenance records are maintained.

Education & Qualifications:
Relevant Engineering Qualification i.e., Level 7 or Level 8 Mechanical

Required Skills:
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, PowerPoint).
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.
Strong verbal and interpersonal skills
Competent level of technical writing and understanding of technical documentation.
Full clean driving licence required.
Must be eligible to work in Ireland

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