MS&T Process Engineer – GMP Sterile Fill/Finish

PSC Biotech; Melbourne; Vor Ort; AUD 90.000 - 130.000; Vollzeit

Zusammenfassung

PSC Biotech in Melbourne, Australia, is seeking a Process Engineer in MS&T to support technology transfer, process implementation, commissioning, qualification and validation in a GMP manufacturing setting. The role focuses on sterile fill-finish operations and cross-functional collaboration to deliver compliant manufacturing solutions.

The candidate will author and execute DQ/FAT/SAT/IQ/OQ/PQ/PV protocols, develop CQV documentation and validation strategies, and lead process improvement

Qualifikationen

• Bachelor’s degree in Engineering or life sciences; GMP environment preferred.
• 3+ years' experience in MS&T, Process Engineering, CQV, or Manufacturing Support within GMP environment.
• Experience with technology transfer, commissioning, qualification, and validation activities.
• Strong understanding of GMP, Annex 1, PIC/S, risk management, and change control.
• Experience with fill-finish operations, filling lines, and aseptic processing.
• Excellent stakeholder management, project coordination, and client-facing communication skills.
• Exceptional interpersonal skills to communicate across organizational levels.

Aufgaben

• Lead technology transfer activities and support facility, process, and technology upgrades.
• Author, execute, and review DQ, FAT, SAT, IQ, OQ, PQ, and PV protocols and reports.
• Develop CQV documentation, SOPs, validation strategies, and final reports.
• Support design reviews, risk assessments, change controls, and process optimisation initiatives.
• Coordinate Engineering, Quality, Operations, Automation, and Regulatory teams through qualification, commissioning, and operational readiness activities.
• Support fill-finish manufacturing processes including vial filling, PFS, lyophilisation , sterile filtration, aseptic processing, bulk product, and plasma manufacturing.
• Provide technical support for vendor qualification, FAT/SAT, troubleshooting, and continuous improvement projects.

Kenntnisse

Relationship Building

Negotiation Skills

Organization

Analytical Skills

Rational Persuasion

Interpersonal Awareness

Agility

Ausbildung

Bachelor’s Degree in Engineering or relative Life Science degree

Jobbeschreibung

PSC Biotech in Melbourne, Australia, is seeking a Process Engineer in MS&T to support technology transfer, process implementation, commissioning, qualification and validation in a GMP manufacturing setting. The role focuses on sterile fill-finish operations and cross-functional collaboration to deliver compliant manufacturing solutions.

The candidate will author and execute DQ/FAT/SAT/IQ/OQ/PQ/PV protocols, develop CQV documentation and validation strategies, and lead process improvement