Project Engineer

Project Engineer - Ireland, Dublin - 12 Month Contract

Are you a Project Engineer looking for your next challenge in Dublin? A leading multinational in Ireland’s thriving biopharma industry is expanding their team for a major facility development.

This project provides hands‑on experience with innovative equipment, large‑scale operations, and modern pharmaceutical technologies. It’s an ideal opportunity to build your skills within one of Europe’s fastest‑growing life‑science regions.

What you’ll do:

• Develop a strategy to ensure that the validation approach for the new SDP facility satisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective and appropriate use of process development.
• Development and execution of Cycle Development and PQ activities for autoclaves and SIP systems according to the SDP Validation Master Plan.
• Produce and maintain appropriate and comprehensive validation policies and procedures.
• Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.
• Ensure the review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures.

What you’ll need:

• Deep technical knowledge of Sterile Drug Product manufacturing equipment validation and sterilisation. Specifically in the areas of sterile filling and associated equipment.
• Knowledgeable on current industry practices and regulatory requirements within the Sterile Drug Product manufacturing area.
• First-hand experience of qualification and validation of Sterile Drug Product manufacturing equipment and/or processes. Specifically in the area of Sterile Filling and Isolator equipment.
• The successful candidate must possess a Bachelor/master's in engineering, or Science related discipline. 
• Extensive experience within a Sterile Drug Product Manufacturing is essential.

Be part of something bigger. Start your application today.

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