Fill Finish Engineer

1w1 week ago

PSC Biotech

Melbourne, AU · Full-time · A$130,000 – A$170,000

About this role

We are looking for a Fill Finish Engineer to join our team on a 12-month contract. This role plays an essential part in supporting the technical transfer of processes and products into GMP manufacturing. It demands a strong understanding of fill & finish processes and effective collaboration with project teams.

The Fill Finish Engineer assists in creating key documentation, ensures project milestones are tracked, and provides hands-on support in cleanroom environments. Daily tasks involve partnering as the Fill Finish SME in a greenfield fill & finish process. Oversight of automation readiness integrates systems with filling lines while meeting validation requirements.

Work closely with GMP manufacturing, capital project teams, and the Fill Finish team to achieve milestones and attend recurring meetings. Collect and trend process data for client and internal review. Support MES recipe startup, debugging, and documentation updates for process optimization.

Assist with training GMP manufacturing staff on client processes and provide deviation resolution support. Operate in a dynamic environment focused on regulatory compliance and qualification. This position offers involvement in greenfield projects within pharmaceutical GMP settings.

Requirements

Strong understanding of fill & finish processes
Experience supporting technical transfer into GMP manufacturing
Knowledge of cleanroom environments and hands-on support
Familiarity with automation systems integration for filling lines
Proficiency in validation protocols and regulatory compliance
Ability to document engineering tests and validation reports
Experience with MES recipe startup and debugging
Understanding of GMP manufacturing processes and deviation resolution

Responsibilities

Partner with GMP manufacturing and capital project teams as Fill Finish SME in greenfield fill & finish process
Oversee automation readiness, ensuring system integration with filling lines and compliance with validation requirements
Document protocols, engineering tests, and validation reports to ensure compliance with regulatory and client requirements
Work closely with Fill Finish team to ensure project milestones are achieved and attend recurring and ad hoc meetings
Collect and trend process data for external client and internal review
Support MES recipe startup, debugging, and documentation updates to align with process optimization efforts
Assist with training GMP manufacturing staff on client processes
Provide deviation resolution and qualification support by addressing process deviations and troubleshooting