- Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
- Monitoring and reporting of process performance using statistical process control
- Generation of data and reports to support Annual Product Reviews and Regulatory submissions
- Troubleshooting of DCS (e.g Delta V) and PLC control systems
- Investigating and resolving Deviations raised within the Manufacturing Department
- Participate in/ Lead Cross Functional teams when required
- Support of Commissioning and Qualification activities
- Preparation and updating of Batch Records, Procedures and Work Instructions
- Provide process and equipment related training as required within the Manufacturing Department
- Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
- Working assigned shift patterns to meet business needs and manufacturing schedule.
QUALIFICATIONS AND EXPERIENCE
- A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
- Postgraduate Qualification.
- Manufacturing experience within a GMP regulated environment.
- Experience of Buffer or Media preparation or Equipment preparation in a manufacturing environment.
- Experience of the cell culture or purification processes in either a manufacturing or a lab based environment.
- Experience of Microsoft Word, Excel and Outlook.
- Experience of DCS (e.g. Delta V), SCADA and PLC systems
- Experience of SAP, LIM's and/or other business systems.
- 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.