Process Engineer Specialist
RK25172
Contract 11 months
Carlow



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Coordinate, execute, and document qualification and process studies and additional product programs where applicable. Respond to operational and business areas, ensuring compliance with cGMP and regulatory requirements.




Key Responsibilities:

• Generation, review, and approval of process documentation.
• Execution of development and qualification studies across commercial and non-commercial products.
• Representing the Technical Operations department at cross-functional meetings.
• Development and qualification of new processes.
• Qualification of new equipment where appropriate.
• Lead and support investigations and troubleshooting of process studies as required.
• Provide technical support for commercial manufacturing.
• Provide technical support for new product introduction.
• Ensure compliance with the QMS and industry/company-specific standards and regulations.
• Demonstrate effective communication and interpersonal skills.
• Apply technical knowledge to enable authoring of technical documents and informed technical decision-making.
• Support audit readiness, including preparation of storyboards, ensuring GMP-compliant documentation is available, and presenting to auditors as required.

• Bachelor’s Degree or higher preferred, ideally in a related Science or Engineering discipline.
• 2+ years experience in pharmaceutical manufacturing facility
• Experience with commercial products from the production side