Laboratory Validation Engineer

The QC Pharma Department is responsible for the qualification/validation of laboratory equipment, systems, and processes used in routine operations at the laboratories. The department also oversees the revalidation of critical systems.

The Validation Engineer's role is to ensure customer satisfaction with each revalidation, validation, and project. All validation activities must align with Global Standards, FDA, HPRA, and other MPH regulatory requirements. Compliance with schedules will be achieved by actively engaging with senior management and affected business units, ensuring all projects are effectively managed and prioritized.

Responsibilities:

• Oversee, coordinate, guide, and implement the site validation master plan under prospective, concurrent, and retrospective validation studies alongside relevant engineers. Ensure all validation requirements are met for any new or modified process or equipment.
• Actively manage validation projects, serving as the departmental point of contact, and complete all project documentation per corporate and regulatory expectations. Ensure documentation for each validation study is compiled, authorized, and filed promptly and systematically. Collaborate with other validation engineers to achieve compliance by coordinating assigned validation projects, reviewing, and approving validation documentation.
• Participate in risk assessments and design review processes for all business units.
• Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire, etc.).
• Facilitate the PQR review process, Regulatory Review Process, and Laboratory Equipment Review Process as per current schedules.
• Stay updated on changing regulatory guidance for relevant validation areas. Support audit preparation, participate in direct audit interactions, and assist with audit responses.
• Comply with internal EHS requirements, procedures, and policies. Ensure continued conformance to the EMS within the department and strive for quality objectives through continuous improvement and adherence to standards. Attend department and APEX meetings and participate in Quality and Safety initiatives.
• Support audit preparation, participate in site audits (internal and external), and take part in the periodic review program.

Qualifications:

• Bachelor’s degree in a science-based or engineering discipline
• Experience in a pharmaceutical company
• Strong project management skills

• Proficient in Microsoft Office
• Critical thinking and problem-solving abilities
• Clear communication skills for interactions with internal and external bodies
• Excellent conflict resolution skills
• Expertise in relevant subject areas such as Equipment, Facility, Aseptics, Process, CPV, CSV, and Cleaning

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Hannah Doyle on 086 107 0950 Engineering@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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