Description:
BMS Cruiserath Biologics is seeking to recruit a permanent Senior Specialist, Downstream Manufacturing ( Senior Downstream Bioprocess Associate) within the Manufacturing Operations group. Reporting to the Shift Lead, the role will support the ongoing manufacturing operations within the facility, as well as qualification activities for new processes and equipment. This is a 24/7 shift role.
Key Responsibilities
- Deliver expert level of execution in manufacturing-process unit operations according to established standard work instructions
- Expert in operation of manufacturing equipment and technology within the functional area
- Technical author and approver for operating procedures & documentation for large-scale manufacturing
- Deliver expertise in training, training content design combined with oversight and approval of Manufacturing Specialist’s on-the-job training and competency
- Driving Right-First-Time execution on shift & front-line support/resolution of manufacturing issues
- Expertise in the use of process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and supporting business systems (i.e. SAP. Trackwise, Maximo etc.)
- Lead shift-based Investigations in QMS and drive effective CAPA implementation
- Oversee real-time review of batch and exception reports for manufacturing lots in conjunction with Quality Assurance team and provide support to QA audit readiness activities
- Driving and promoting Good Manufacturing Practices Good Documentation Practices and adherence with Standard Operating Procedures
- Operating to and maintaining dynamic schedules - in a fast-paced production environment
- Facilitate and support change control and project changes to operations in the MPCC manufacturing facility in collaboration with the Manufacturing Operations group, Technical Transfer Teams, Manufacturing Engineers & the Automation teams
- Support for NPI execution activities and non-routine protocol activities
- Role model and support a culture of continuous improvement and operational excellence
- Ownership and promotion of improvement projects for manufacturing work practices and a safe working environment by application of sound scientific, engineering and lean principles
- Role model of the BMS behaviours and Safety culture
Qualifications & Experience
- The successful candidate would ideally possess a minimum of Level 7 qualification in an Engineering/Science related discipline
- Min. 3-5 years of Downstream experience in a large-scale biopharmaceutical manufacturing facility is a must
- Competence with Delta V and MES or similar control and data acquisition systems would be required
- Automation experience should include an ability to troubleshoot and run technical queries and reports in support of investigations and Data Integrity
- Manufacturing and automation expertise and demonstrated ability to work independently and as part of a team.
- Demonstrated problem-solving ability and the ability to work proactively to achieve demanding schedules
- High proficiency in communication and collaborating at a variety of levels and the ability to work in a cross-functional and fast-paced team environment
- Working flexibly to react to changing business needs.
- Proven ability to support the close-out of complex investigations and good GMP awareness.
- Proven ability to operate, maintain and troubleshoot bench analytical equipment supporting manufacturing processes