Validation Engineer – Sterile Injectables | Equipment

Role Summary:

• Are you a highly skilled Validation Engineer ready to play a critical role in safeguarding global patient health? Join a top tier, international healthcare organisation dedicated to the reliable manufacturing of essential sterile injectable medicines.
• We are looking for an expert to ensure our cutting edge manufacturing equipment and systems in Galway are fully qualified and compliant with the world’s most stringent standards.
• This is a confidential and impactful opportunity within the core Technical Services function, where your expertise directly contributes to product quality and patient safety.
• Our client is looking for a hands on engineer to drive the full validation lifecycle, from planning to final reporting.
• This is a contracting position.

Core Duties and Responsibilities:

• Lead and execute the entire qualification lifecycle, focusing on Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for critical sterile manufacturing equipment and utilities.
• Ensure absolute compliance with global regulatory standards, including cGMP, FDA, EMA, and Annex 1 requirements for all validation activities.
• Be the site technical expert for Sterility Assurance, applying and maintaining knowledge of autoclave and depyrogenation tunnel operation, thermocouple calibration, and the handling of biological indicators.
• Perform comprehensive risk assessments (e.g., FMEA) to define robust and compliant validation strategies and critical process parameters.
• Manage investigations, analyse validation results, and generate technical reports for regulatory readiness and internal documentation.

Minimum Qualifications and Experience:

• A degree in Engineering (e.g., Mechanical, Chemical, Electrical, or equivalent).
• Proven experience as a Validation Engineer or equivalent in a highly regulated pharmaceutical or medical device environment.
• In depth knowledge of equipment qualification and validation principles, specifically within aseptic or sterile injectable manufacturing.
• Expertise in Good Manufacturing Practices (GMP) and current industry validation guidelines.

Take the Next Step:

If you are a dedicated validation professional who is passionate about quality and ready for a challenging role in Galway, apply today.

Please note, we do not require agency assistance with this role.