Quality & Validation Specialist (Medtech)

TL;DR

Quality & Validation Specialist (Medtech): Supporting validation, quality, and laboratory activities within a regulated medical device or pharmaceutical manufacturing environment with an accent on GMP, ISO, and regulatory compliance. Focus on executing IQ/OQ/PQ protocols, investigating deviations, and performing root cause analysis to ensure system reliability and safety.

Location: On-site in Dublin, Ireland

Company

The largest pureplay adhesives company in the world, providing innovative coatings, adhesives, and sealants across various market segments globally.

What you will do

• Execute and document process, cleaning, analytical method, and equipment validation activities.
• Support equipment and system qualification including IQ/OQ/PQ.
• Prepare and review validation protocols, reports, risk assessments, and supporting documentation.
• Investigate deviations, non-conformances, and out-of-specification (OOS) results.
• Perform root cause analysis and support CAPA development and effectiveness reviews.
• Interpret analytical data using techniques such as HPLC, GC, UV, and FTIR.

Requirements

• Bachelor's degree in Chemistry or a related scientific discipline.
• 2–5 years of experience in pharmaceutical, medical device, or regulated manufacturing environments.
• Hands-on experience with process, cleaning, analytical, or equipment validation.
• Knowledge of GMP, ISO 13485, FDA, or EU regulatory requirements.
• Strong technical writing, documentation, and problem-solving skills.

Nice to have

• Postgraduate qualification or certification in Quality or Validation.
• Experience supporting FDA, EMA, or Notified Body inspections.
• Knowledge of risk management tools such as FMEA, HACCP, Fishbone, or 5 Whys.
• Experience with electronic Quality Management Systems (eQMS).
• Familiarity with automation testing, scripting, or GAMP5 frameworks.

Culture & Benefits

• Collaborative culture where employees are seen, heard, and respected.
• Opportunity to work for a global leader in the adhesives industry.
• Equal Employment Opportunity employer.