We are seeking to recruit a Specialist, Downstream Manufacturing (Downstream Bioprocess Associate) within the Manufacturing Operations group. Reporting to the Senior Manager, Downstream Manufacturing Shift Lead, the Specialist will support the ongoing manufacturing operations within the facility, as well as commissioning and qualification activities for the process equipment where required. This is a 24/7 shift role.
Key Duties and Responsibilities: Working with the manufacturing operations group, project design team, the CQV team, & the Automation/CSV reps to facilitate the implementation of the project design and validation of the MPCC manufacturing facility.Creation of operating procedures & other relevant documentation for large scale manufacturing.Execution of commercial manufacturing processes according to established work instructions.Adheres to Good Manufacturing Practices and Standard Operating Procedures.Takes part in investigations and optimisations of processes using scientific, engineering and lean principles.Operates all production equipment within the assigned functional area.Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP, Trackwise, Maximo etc.).Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative and provides input to related investigations and QA audit activities.Engages in and supports a culture of continuous improvement and operational excellence through ownership of improvement for work processes, equipment and a safe work 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).Ideally possess 1-3+ years' working experience in a large-scale biopharmaceutical manufacturing facility.Experience with Delta V and MES would be considered an advantage.The successful candidate must demonstrate an ability to work independently and also as part of a team.The successful candidate must demonstrate problem-solving ability and adhere to scheduled timelines.Excellent communication skills and the ability to work in a cross-functional collaborative environment are required.Due to the nature of the manufacturing role, shift work will be required for 24/7 mode of operations.
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