Process Scientist / Engineer
- Sligo
- Permanent
- Full-time
- This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
- This is an exciting time to join our clients Technical Operations team as they grow and bring new products and technologies to the site.
- There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
- Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
- Work closely with site cross-functional team and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes.
- Lead and / or assist risk assessments for the introduction or modification of the product path including single use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities.
- Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints.
- Assist with the development of manufacturing process for new products including developing and/or reviewing process related documents e.g., Protocols/ Procedures/ Manufacturing Batch Records.
- Prepare and update specifications related to NPI materials and consumables, including single use materials used in the product path.
- Provide operational technical support for process related issue resolution, design experiments to investigate new processes or failure modes, assist and / or lead single use process related investigations.
- Monitor and analyse process data during the manufacturing.
- Support, supervise, and train operations personnel for SU processes.
- Adhere to and support all EHS&E standards, procedures, and policies. Other duties as assigned.
- Degree in science, engineering, or other relevant technical subject area
- 2+ years direct experience in the use of single use materials for biologics manufacturing in GMP environment e.g., in operations, technical operations, and process validation.
- 1+ years experience in the design, onboarding, and qualification of single use assemblies for biologics manufacturing
- Experience in client-facing role collaborating with vendors and global stakeholders to advance.