BioProcess Associate

Description

• Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative and provide input to related investigations and QA audit activities.
• Creation of operating procedures & other relevant documentation for large scale manufacturing
• Takes part in investigations and optimisations of processes using scientific, engineering and lean principles
• Operates all production equipment within the assigned functional area
• Execution of commercial manufacturing processes according to established work instructions.
• 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.
• Engages in and supports culture of continuous improvement and operational excellence through ownership of improvement for work processes, equipment and safe work environment.

Requirements

• The successful candidate must demonstrate an ability to work independently and also as part of a team.
• Excellent communication skills and the ability to work in a cross functional collaborative environment are required.
• Adheres to Good Manufacturing Practices and Standard Operating Procedures.
• 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)
• Requires extensive working experience in a large-scale biopharmaceutical manufacturing facility
• 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.).
• The successful candidate must demonstrate problem solving ability and to adhere to scheduled timelines.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance