In this role, you will be presented with exciting and challenging opportunities to work on multiple projects, ranging from manufacturing support activities, to late stage clinical product development and scale-up, new product introductions and technology transfers.
As part of the high performing technical operations team, you will optimise troubleshoot and develop processes to ensure the highest quality product is manufactured at our API facility. While your primary focus will be supporting the API facility, you will have the potential opportunity to build your drug product process knowledge as part of the team.
Key Responsibilities Include:
- Provide engineering support to all manufacturing and control system related issues. Tasks include, daily trouble shooting, optimisation, cost reduction, training and coaching of manufacturing personnel.
- Leadership of all commissioning and validation activities during project start-up.
- Planning and leadership of technical transfers for future product introductions to the site. To accomplish this, you will be part of cross functional teams both within the site and globally.
- Process and equipment optimisation in order to sustain and improve product quality, yields and throughput. Making recommendations and implementing measures to improve production systems, equipment performance, yields and quality of product.
- Interfacing with new product development groups to integrate new products into the Sligo facility either as new process development entities or as product transfer from another manufacturing facility. Supporting migration of process knowledge for product technical transfers from facility.
- Execution of process development on existing products or new late stage clinical products including scale up to plant equipment.
- Identifying continuous improvement activities and leading or participating in cross-functional teams to implement. Supporting activities in the areas of cost reduction, process efficiency and operational excellence.
- Providing on-the-floor technical support to the Production Team Leaders for process/equipment optimization and troubleshooting.
Education & Experience:
- A relevant third level Degree or higher qualification in chemical engineering, process engineering or related technical discipline
- Preferable 3 years’ experience in process engineering, or recent high calibre graduate with strong technical depth will be considered.
- Relevant experience of batch processing, automation, technical transfers, scale up, commissioning and validation in a cGMP pharmaceutical industry.
- Experience in new product introductions to pharmaceutical facilities is desirable.
- Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required.