Validation Manager

Job Opportunity: Validation Manager - Sligo

Industry: Biologics / Pharmaceutical

Employment Type: Full-Time

Our client, a leading biopharmaceutical organization, is currently seeking an experienced Validation Manager to join their state-of-the-art facility in Sligo. This is a fantastic opportunity to play a pivotal role in leading and developing a site-wide validation program in a fast-paced, regulated environment.

Key Responsibilities:

• Lead a team of validation professionals, providing guidance and oversight for all validation activities on site.
• Manage the qualification and validation of equipment, utilities, processes, and software, ensuring alignment with internal policies and external regulatory standards (FDA, EMA, cGMP, GAMP).
• Develop and maintain comprehensive validation project plans, protocols, and reports, ensuring full compliance with cGMP.
• Review, approve, and oversee execution of validation and qualification documentation and manage associated deviations and change controls.
• Provide Quality Assurance support for validation-related investigations, including implementation of corrective and preventive actions.
• Ensure accurate documentation of all validation work in accordance with regulatory expectations.
• Support onboarding and training of new team members and engage in cross-training initiatives.
• Drive continuous improvement efforts across manufacturing, quality, safety, and training systems.
• Collaborate across departments to enhance operational effectiveness and support strategic business goals.
• Represent the validation function in cross-functional and cost-improvement initiatives.

Requirements:

• A qualification or degree in Engineering, Science, or a related discipline.
• Minimum 3 years' validation or quality experience in a cGMP regulated, sterile/aseptic environment, with specific exposure to commissioning and qualification.
• At least 2 years of team leadership or people management experience.
• Proven knowledge of current Good Manufacturing Practices and regulatory expectations in the pharmaceutical industry.
• Strong communication, presentation, and analytical skills.
• Demonstrated ability to lead teams, manage priorities, and work both independently and collaboratively.