Join a World-Leading Biopharma Innovator in Ireland!
Our client is operating are a state-of-the-art Biologics aseptic fill-finish facility, and we are looking for a highly skilled Single Use Process Specialist (Scientist/Engineer) to join their Technical Operations Team in Sligo, Ireland.
This is an exciting opportunity to be at the heart of New Product launches and technological advancements. You'll be part of a global team, playing a critical role in the evolution of the single-use materials that are essential to our biologics manufacturing processes. This is a chance to make a real impact on patient health and grow your career with a global leader.
What You'll Do:
- Innovate and Develop: Work closely with our global science and quality teams to develop and evolve the single-use materials used in our cutting-edge biologics manufacturing processes.
- Lead with Expertise: Take the lead on risk assessments (like pFMEA and SU RA) for new materials, ensuring seamless integration and compliance.
- Collaborate and Connect: Serve as the technical lead for single-use complaints, interacting directly with manufacturers and vendors to ensure best practices and validate new technologies.
- Drive New Products: Help develop manufacturing processes for new products, creating and reviewing key documents like Protocols and Batch Records.
- Resolve and Optimize: Provide critical technical support for process issues, design experiments to investigate new processes, and lead single-use process-related investigations.
- Mentor and Train: Support and train operations personnel on new single-use processes, sharing your knowledge and expertise.
Who We're Looking For:
- A degree in science, engineering, or a related technical field.
- At least 2 years of direct experience with single-use materials in biologics manufacturing within a GMP environment.
- A minimum of 1 year of experience in the design, onboarding, and qualification of single-use assemblies.
- Proven experience collaborating with vendors and global stakeholders in a client-facing role.
If you're an initiative-taking professional with strong collaboration skills and a passion for innovation, we want to hear from you. Join us in Sligo, where your expertise will help bring new products to life and shape the future of biopharma.
