Specialist, Upstream Manufacturing
Reporting to the Senior Manager, Upstream Manufacturing Shift Lead, the Specialist, Upstream Manufacturing will support the ongoing manufacturing operations within the facility, as well as commissioning and qualification activities for the process equipment.
This is a 12/7 and 24/7 shift role.
Key Duties and Responsibilities:
· Execution of commercial manufacturing processes according to established work instructions
· Creation of operating procedures & other relevant documentation for large scale manufacturing
· Operating production equipment within the assigned functional area
· Adhering to Good Manufacturing Practices and Standard Operating Procedures
· Taking part in investigations and optimisation of processes using scientific, engineering and lean principles
· Proficient use of process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.)
· Assisting with review of batch and exception reports for manufacturing lots in conjunction with Quality Assurance representative and provide input to related investigations and QA audit activities
· Working with the manufacturing operations group, the project design team, the CQV team, & the Automation/Computer Systems Validation teams to facilitate the implementation of the project design, validation and operation of the MPCC manufacturing facility
· Engages in and supports culture of continuous improvement and operational excellence through ownership of improvement for work processes, equipment and a safe working environment
Qualifications, Knowledge and Skills Required:
· The successful candidate will ideally possess a minimum of Level 6 qualification in an Engineering/Science related discipline; however, relevant experience in a similar regulated industry will also be considered (e.g. cGMP, ISO or similar cleanroom industry experience strongly preferred)
· Working experience in a large-scale biopharmaceutical manufacturing facility would be a distinct advantage
· Experience with Delta V and MES or similar control and data acquisition systems would be desirable
· The candidate must demonstrate an ability to work independently and also as part of a team.
· A successful candidate will have a demonstrated problem-solving ability and the ability to adhere to scheduled timelines
· Excellent communication skills and the ability to work in a cross-functional, collaborative and fast-paced environment are essential
