ACCOUNTABILITIES:

• Deputise for shift management where required - leading manufacturing teams, coordinating production activities, and acting as a plant representative in cross-functional groups.
• Instigate, explore, and evaluate opportunities to use technology – including AI, to improve production activities in the pursuit of next-generation processes including autonomous manufacturing.
• As a key member of the operations team, carry out multi-stage Active Pharmaceutical Ingredient (API) manufacturing processes in compliance with AstraZeneca, GMP & SHE standards.
• Provide operational expertise at accommodation meetings such as processing risk assessments.
• Reinforce standards required in terms of GMP, SHE, and specific product requirements.
• Set-up routings for production, changeover and cleans, and maintain relevant equipment to enable the smooth running of the plant unit.
• Receive, accept, locate, store, dispatch and deliver products and materials and complete all relevant documentation to meet GMP and SHE standards.
• Collaborate with the relevant function to receive and return the materials/components that feed into the production process.
• ERT membership will be included as a core responsibility.

ESSENTIAL SKILLS/EXPERIENCE:

• Minimum NFQ level 7 or equivalent in a scientific or engineering discipline (or able to demonstrate comparable proficiency) with history of positive application.
• High level of API, Pharmaceutical or other complex manufacturing experience, with skills to support planning, managing, and monitoring of major manufacturing production projects from concept to implementation.
• Ability to embrace and apply innovative engineering and digital technologies to drive enhanced production processes.
• Data driven to evaluate process performance and able to apply problem-solving skills to drive improvement opportunities.
• Able to drive improvement plans, priority setting, investigation reports, quality or performance improvement recommendations to completion.
• Able to make complicated judgements and anticipate future manufacturing production developments.
• Strong safety attitude, ensuring compliance against Safety, Health and Environment standards.
• Excellent Documentation Practices, GMP and regulatory knowledge/awareness.

DESIRABLE SKILLS/EXPERIENCE:

• Team or project management.
• Previous start-up experience.
• Documentation generation (drafting initial SOPs, MBR, LIMS sampling plans etc).
• Familiar with manufacturing systems e.g. Delta V.
• Lean qualification.
• Familiarity with Electronic batch record design and use.
• Experience in investigations, CAPA’s and change controls.
• Awareness and understanding of process equipment and TPM.

Are you ready to make a difference? At AstraZeneca, we’re taking bold actions to revolutionize the way life-saving medicines are produced. Our new digital smart and paperless factory near Dublin, Ireland, is set to transform API manufacturing, enabling continuous production that delivers medicines faster, cheaper, and more sustainably. This cutting-edge facility will optimize our processes and enhance efficiency using advanced technology and digital innovations. Join us in this shift position where you’ll engage in manufacturing activities and deputize for shift management when needed.