- Drive Process Understanding, Capability and Continuous improvement projects to support the site strategy, delivering safe, compliant and robust operations from a Process Engineering perspective.
- Involved in, process design and generating innovative engineering solutions to drive continuous improvement.
Core Duties and Responsibilities:
- Provide technical leadership in the application of process engineering best practice, principles and process safety on a variety of key projects across site, global supply and process capability improvements to the supply chain.
- Recognised as key point of contact for all aspects of technical knowledge on manufacturing unit operation(s) for which he/she is responsible for, including ensuring Critical Process Parameters are identified, understood, monitored and controlled.
- Provide process engineering support for Product Lifecycle Management, including input to Technical Risk Assessment (and escalation), development and use of Product Control Strategies for new and mature products, Product Performance Monitoring and assessment, and maintenance of knowledge management associated with dose/product form.
- Use of GPS tools such as RCA to problem solve Technical issues related to the dose/product form
- Lead process improvement projects on site, ensuring appropriate technical change control to deliver robust, sustainable solutions
- Execute key technical activities including trials, improvement projects, RCAs, validation activities where appropriate
- Lead/support design and development work in support of equipment selection, installation and validation (including business process change) and support the standardisation of manufacturing and process measurement technology (e.g. PAT) on site
- Support the identification of Critical Process Parameters (CPP) for all new and existing products, to ensure appropriate control systems are in place for robust process operations. Where applicable, liaise with process measurement technology (PMT) experts to understand the relationship between measurement, impact of variability in raw materials and intermediates, environmental conditions, equipment conditions, manual operations and their integration with the control strategy.
- Investigate alternative new technologies for plant/equipment efficiency improvements and use technical expertise to influence equipment strategy to meet future site goals
- Ensure compliance with site standard operation procedures
- Ensure that GMP, Quality, Health and Safety processes are adhered to in all aspects of role
- Work with other site functions to ensure appropriate technical capability is in place e.g. operational staff
- May be responsible for leading other process engineers, where required.
Minimum Qualifications and Experience:
- BSc/BEng in Process or Chemical Engineering or related Engineering discipline
- Experience of Pharmaceutical/FMCG or other regulated industry
- Experience of working in a regulated environment
- Operational knowledge of manufacturing equipment
- Ability to contribute to and effectively influence matrix teams and colleagues in other functions
- Track record of improving products, processes and trouble-shooting
- Knowledge of GMP requirements
- Previous Process safety experience
- Experienced in technology transfer, with an understanding of the product development process
- Able to evaluate potential innovative technology areas relevant to product
- Knowledge of Quality by Design and risk management approaches
- Knowledge and experience of using statistics, data analysis, MSA, DoE
- Project management skills
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.