Microorganism Specialist

Join a leading medical device organisation as they continue to grow their team. We are working with an award-winning industry leader in the field of Microbiology.

• Support method transfer, validation and engineering qualification activities
• Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies
• Provide key support and technical expertise to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems
• Take the lead and provide direction in all areas relating to the microbiological validation of the product
• Responsible for microbiological systems and associated documentation updates post validation, ensuring they remain current and in compliance to regulatory standards and corporate requirements
• Provide functional expertise to other support functions (e.g. regulatory requirements, statistical techniques, sampling principles)

• Third level qualification in Microbiology or related discipline
• Ideally 2-5 years' experience within a pharmaceutical GMP environment
• Previous working experience with NPI projects with knowledge and application of Microbiology principles associated
• Previous bioburden and endotoxin validation experience
• Excellent interpersonal and communication skills with good leadership abilities
• Strong Decision-making skills and ability to work on one's own initiative

This is a confidential opportunity. If you have the required skills and experience, contact Barry O'Brien for more information and to discuss the role further.