Assoc. I, Spclst Operations Intern

Manufacturing Technical Operations Internship

This role will be part of our Manufacturing Technical Operations Team in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. You will support the development of the site by participating in cross functional teams to deliver all project milestone, supply, and commercialisation activities with a safety first, quality always mindset. The Manufacturing Technical Operations Internship involves driving commercial operations, continuous improvements and standard work principles at the single use multi-product biotech facility by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.

Responsibilities:

• Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations: change control management and implementation, closure of significant technical investigations, process improvement opportunity identification through implementation, regulatory license section authoring through response-to questions, health authority inspection SME support, and more.
• Work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production within the IPT area.
• Have an understanding of specific EBRs in the facility, making technical changes are required to meet the demands of the business or in response to any requirements for process changes that may occur.
• Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility.
• Support/Drive future updates to the batch recipe on the PAS (process automation system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.
• Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan.
• Resolve issues and identify risks and escalate in a timely fashion.

What We're Looking For:

• Currently pursuing a qualification in Science, Engineering or related discipline.
• Collaboration, negotiation & conflict resolution skills.
• Excellent communication skills (written and oral).
• Ability to multi-task and handle tasks with competing priorities effectively.