Join a team in one of Ireland’s most picturesque towns – Westport, Co. Mayo – known for its vibrant community, stunning natural beauty, and exceptional quality of life.
Job Summary
The Validation Engineer will be responsible for ensuring the qualification and validation of CGMP equipment, systems, and processes in line with the highest global standards and regulatory requirements. In this role, the Validation Engineer will lead validation projects, manage documentation, and ensure compliance with standards from regulatory bodies such as FDA and HPRA. This is an exciting opportunity to contribute to critical manufacturing processes, ensuring continuous improvement and operational efficiency.
Key Responsibilities
- Lead and coordinate the Validation Master Plan across site projects, overseeing prospective, concurrent, and retrospective validation studies for new processes, equipment, or modifications.
- Ensure all validation documentation is completed, authorised, and organised according to current corporate and regulatory expectations.
- Serve as the key contact for validation projects, collaborating with senior management and business units to ensure projects are prioritised and managed efficiently.
- Participate in risk assessments and design reviews for various business units, contributing to the overall compliance strategy.
- Monitor and track metrics related to validation work, generating reports and updates as needed.
- Stay informed about changing regulatory guidance and ensure compliance with relevant standards.
- Support internal and external audit preparation, participate in audit responses, and provide expert insights during audits.
Qualifications
- Bachelor’s degree in a science-based or engineering discipline.
- Experience working in the pharmaceutical industry.
- Proficient in Microsoft Office.
- Strong project management and problem-solving skills.
- Excellent communication and conflict resolution abilities.
- Expertise in areas such as Equipment, Facility, Aseptic Processing, Process Validation, CPV (Continued Process Verification), CSV (Computer Systems Validation), and Cleaning Validation.
This is an opportunity to work in a collaborative and innovative environment, ensuring quality standards are met and exceeded in a cutting-edge manufacturing setting.
For further information on this role, please contact Diarmuid Lannon on +353 861287246 or email consulting@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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