Eirdata Head of Validation

Cork
4 days ago
Create job alert

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

Related Jobs

View all jobs

Eirdata Electrical Site Lead

Get the latest insights and jobs direct. Sign up for our newsletter.

By subscribing you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Negotiating Your Biotech Job Offer: Equity, Bonuses & Perks Explained

How to Secure a Compensation Package That Reflects Your True Value in the UK’s Thriving Life Sciences Sector Introduction Biotechnology is one of the most dynamic and impactful sectors in today’s global economy—particularly in the UK, which boasts a thriving research ecosystem and a burgeoning community of innovative start-ups. From cutting-edge work on gene editing and CAR-T therapy to breakthroughs in diagnostics and personalised medicine, the biotech field promises vast opportunities for mid‑senior professionals to make a meaningful difference. However, with these opportunities comes the need for careful negotiation when evaluating a new role. Biotech companies—whether they’re large pharmaceutical giants or lean start-ups—often structure compensation packages that go far beyond simple salaries. These may include equity grants, performance-based bonuses, and a range of perks designed to attract top talent in a competitive market. Focusing solely on your base salary could mean missing out on substantial long-term rewards or lifestyle benefits. In biotech, your contributions might directly influence life-changing products, high-stakes clinical trials, or novel therapeutic approaches. Hence, your compensation should reflect both the immediate and future value you bring. This article aims to be your comprehensive guide to negotiating a biotech job offer in the UK. We’ll delve into why negotiation goes beyond salary, how equity functions in the biotech context, and how performance bonuses and other perks can amplify the overall value of your compensation. Geared for mid‑senior professionals, this guide offers actionable insights to help you secure a holistic compensation package that aligns with your expertise, future goals, and the impact you will have on advancing life sciences.

Biotech Jobs in the Public Sector: Where to Find Meaningful Careers Across the NHS, Research Councils, and Beyond

Biotechnology has become one of the most vibrant and impactful fields of the 21st century, transforming everything from healthcare and pharmaceuticals to agriculture and environmental conservation. In the UK, the public sector is at the forefront of many biotech initiatives, supported by world-class research institutions, government bodies, and large-scale healthcare networks such as the National Health Service (NHS). For professionals seeking purpose-driven work, biotech jobs in the public sector present a compelling opportunity to blend scientific innovation with a meaningful impact on society. Whether you aspire to develop cutting-edge therapies for chronic diseases, optimise food production in a sustainable way, or champion environmental conservation, the public sector’s broad remit means there are numerous pathways to explore. In this article, we’ll delve into the biotech jobs landscape within the UK public sector—shedding light on why biotechnology is crucial for government bodies, which organisations are leading the charge, and the types of roles available. We’ll also discuss the skills needed to excel in these positions, potential salary ranges, and how to successfully apply. By the end, you’ll have a clearer picture of how you can leverage your biotech expertise to serve the nation through a public sector career.

Contract vs Permanent Biotech Jobs: Which Pays Better in 2025?

In the ever-advancing world of life sciences, biotechnology has emerged as one of the fastest-growing and most impactful sectors in the UK. From gene editing and regenerative medicine to synthetic biology and vaccine development, British biotech organisations are at the forefront of scientific innovation. With this growth comes a high demand for skilled professionals—scientists, data analysts, regulatory affairs specialists, bioprocess engineers, and more—who can help bring cutting-edge treatments and products to market. However, as the biotechnology landscape in the UK continues to expand, so too do the ways in which professionals choose to work. Beyond traditional permanent employment, many biotech specialists are exploring the world of contracting, which can take the form of day‑rate consulting or fixed-term contracts (FTC). Each path promises unique advantages and disadvantages, from pay rates and benefits packages to career development and job security. This article offers a comprehensive guide on contract vs. permanent biotech jobs in 2025. We will explore how the UK biotech sector is shaping up, break down the different types of employment arrangements, and present sample take‑home pay scenarios for each. Our goal is to empower you with the knowledge needed to make an informed decision that aligns with both your financial aspirations and long-term career goals within the vibrant and evolving biotech industry.