We are currently seeking an experienced Isolator Technical Specialist to join an onsite project team in Melbourne, Australia. This role is critical in supporting the setup, qualification, operation, and troubleshooting of isolator technology within a regulated GMP pharmaceutical manufacturing environment. The ideal candidate will bring hands-on expertise in isolator systems and a strong understanding of sterile manufacturing processes in the Life Sciences sector.
Key Responsibilities:
-
Provide technical leadership for isolator-related activities, including installation, commissioning, and qualification (IQ/OQ/PQ).
-
Troubleshoot mechanical and automation issues related to isolator systems.
-
Support the integration of isolators with filling lines and other cleanroom equipment.
-
Work closely with engineering, validation, and quality teams to ensure compliance with GMP and regulatory standards.
-
Author and review technical documentation such as URS, SOPs, protocols, and reports.
-
Train and support operators and maintenance personnel on isolator systems.
-
Participate in risk assessments and deviation investigations related to isolator operations.
Requirements:
-
Bachelor’s degree in Engineering, Life Sciences, or a related field.
-
3+ years of relevant experience working with isolator technology in GMP-regulated pharmaceutical or biopharmaceutical environments.
-
Strong understanding of aseptic processing, barrier technologies, and contamination control.
-
Hands-on experience with isolator manufacturers such as SKAN, Getinge, or comparable systems is highly desirable.
-
Solid knowledge of international regulatory guidelines (FDA, EMA, PIC/S).
-
Proven ability to work collaboratively across cross-functional teams.
-
Excellent communication and problem-solving skills.
Preferred Qualifications:
-
Familiarity with automated filling lines integrated with isolators.
-
Previous experience supporting equipment FAT/SAT activities.
Project Details:
-
Duration: 6 months (with potential extension)
-
Location: Onsite in Melbourne, VIC