
Deputy Shift Production Leader Technologist - APICOM
- Ireland
- Permanent
- Full-time
- 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.
- 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.
- 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.