Senior Validations Engineer

Job title:

Senior Validations Engineer

Company

Hero Recruitment

Job description

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.ieCheck out all our open jobs on our HERO Recruitment website –Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Expected salary

Location

Galway

Job date

Fri, 09 May 2025 04:34:37 GMT

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