Specialist, Upstream Manufacturing
This role reports to the Senior Manager, Upstream Manufacturing Shift Lead, and supports ongoing manufacturing operations within the facility. The specialist will also commission and qualify process equipment.
Key Responsibilities:
* Execute commercial manufacturing processes according to established work instructions
* Create operating procedures and other relevant documentation for large-scale manufacturing
* Operate production equipment within the assigned functional area
* Adhere to Good Manufacturing Practices and Standard Operating Procedures
* Participate in investigations and optimization of processes using scientific, engineering, and lean principles
* Proficiently use process automation systems (e.g., Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (e.g., SAP, Trackwise, Maximo)
* Assist in reviewing batch and exception reports for manufacturing lots with Quality Assurance representatives and provide input to related investigations and QA audit activities
* Work with the manufacturing operations group, project design team, CQV team, and Automation/Computer Systems Validation teams to implement project designs, validate, and operate the MPCC manufacturing facility
* Promote a culture of continuous improvement and operational excellence through ownership of improvement for work processes, equipment, and safe working environments
Qualifications and Skills:
* A minimum of Level 6 qualification in an Engineering/Science-related discipline or equivalent experience in a regulated industry (e.g., cGMP, ISO)
* Working experience in a large-scale biopharmaceutical manufacturing facility is advantageous
* Experience with Delta V and MES or similar control and data acquisition systems is desirable
* Able to work independently and as part of a team, with problem-solving skills and adherence to scheduled timelines
* Excellent communication skills and ability to work in a cross-functional, collaborative, and fast-paced environment