Job Description

Senior Validations Engineer (6-Month Contract)
Location: Galway
Industry: Medical Devices

An exciting opportunity has arisen with an early-stage medical device company that is developing an innovative solution for the treatment of Benign Prostatic Hyperplasia (BPH). BPH is a common condition that affects over 50% of men over the age of 50, often resulting in significant discomfort and a diminished quality of life. Current treatment options are frequently invasive or ineffective, leading many patients to delay intervention.

To support continued development and manufacturing efforts, we are seeking a Senior Validations Engineer on a 6-month contract basis. This role will be integral to advancing validation activities associated with the manufacture and testing of a novel urological device.

Key Responsibilities:

• Lead the development and approval of validation documentation including protocols, records, and reports.
• Execute and oversee process and test method validation activities in collaboration with Operations, R&D, and Quality Assurance teams.
• Ensure timely completion of validation activities in alignment with project milestones and regulatory standards.
• Maintain compliance with Good Manufacturing Practices (GMP) and 21 CFR Part 820 in all validation work.
• Facilitate cross-functional communication to ensure alignment on validation objectives and deliverables.
• Identify, investigate, and resolve validation-related issues, providing technical solutions where needed.
• Report validation progress and outcomes to management, and support regulatory submissions with appropriate documentation.

Qualifications & Experience:

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Minimum of 5 years’ experience in the medical device or pharmaceutical industry.
• Proven experience designing and executing process and test method validations.
• In-depth understanding of ISO 13485 and 21 CFR 820 regulatory frameworks.
• Strong analytical and problem-solving skills, with excellent written and verbal communication.
• Highly organized, self-motivated, and able to work effectively in a cross-functional team environment.

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 Róisín Vaughan on 086 440 3742 / consult@hero.ie

Check out all our open jobs on our HERO Recruitment website - HERO Recruitment: Leading STEM Recruitment Agency 

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