Laboratory Projects Manager

TN Ireland; Cavan; On-site; EUR 55,000 - 70,000; Full time

Job summary

A leading company in healthcare is seeking a Laboratory Validation Manager to oversee validation activities, ensuring compliance with FDA regulations and good laboratory practices. The role involves leading a team, managing projects, and addressing data integrity issues to maintain product quality.

Qualifications

• Knowledge of validation policies and FDA regulations.
• Ability to communicate project changes effectively.

Responsibilities

• Manage validation projects' budgets and resources.
• Lead a team of Laboratory Validation Technicians/Engineers.
• Participate in validation of new equipment and test methods.

Skills

Analytical Skills

Problem-Solving

Interpersonal Skills

Computer Skills

Education

Degree/Diploma in Food Science

Job description

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Company Overview

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritional, and branded generic medicines. With over 107,000 colleagues, we serve people in more than 160 countries.

In Ireland, Abbott operates with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. We employ over 4,000 people across nine sites, including manufacturing facilities in Clonmel, Cootehill, Donegal, Longford, and Sligo, as well as support operations in Dublin and Galway. Abbott has been operating in Ireland since 1946.

Abbott Ireland Nutrition Division - Cootehill, Cavan

Our facility produces infant formulae under the brand "Similac" and follow-on formulae under "Gain." The plant processes milk from approximately 1,000 Irish and Northern Irish farms, producing 500,000 liters daily, which is distributed globally.

Primary Function / Goals / Objectives

• Follow all Environmental, Health, and Safety rules and regulations.
• Report hazards immediately to management.
• Wear appropriate Personal Protective Equipment (PPE) and utilize controls like fume hoods and ventilation.
• Participate in laboratory projects related to continuous improvement, business continuity, and compliance across Analytical, Microbiology, and Incoming Quality Assurance Laboratories.
• Complete validation documentation and assist in validation activities, including installation, qualification, and validation of laboratory equipment, software, and test methods.
• Review SOPs to ensure understanding and compliance.
• Participate in plant projects, conduct audits, and support validation change control processes.
• Assist in internal and external audits, including pre-audit preparations.

Major Responsibilities

• Participate in validation of new equipment and test methods, and in compliance improvement projects.
• Manage validation projects' budgets and resources.
• Lead a team of Laboratory Validation Technicians/Engineers.
• Address data integrity issues and ensure compliance with GLP standards.
• Source, validate, and implement new laboratory equipment.
• Coordinate method transfers and ensure training completion.

Education and Knowledge

• Degree/Diploma or Certificate in Food Science or equivalent scientific discipline.
• Knowledge of validation policies, FDA regulations, and good laboratory practices.
• Strong analytical, problem-solving, interpersonal, and computer skills.
• Ability to communicate project changes effectively and work independently or as part of a team.

Accountability / Scope

Ensuring the validation of laboratory test equipment is critical to product quality, with errors potentially leading to rejected batches. The role involves managing validation activities to uphold standards and compliance.