Isolator Technical Specialist Life Sciences
Isolator Technical Specialist Life Sciences
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Job Description
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 handson expertise in isolator systems and a strong understanding of sterile manufacturing processes in the Life Sciences sector.
Key Responsibilities:
Provide technical leadership for isolatorrelated 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:
Bachelors degree in Engineering Life Sciences or a related field.
3 years of relevant experience working with isolator technology in GMPregulated pharmaceutical or biopharmaceutical environments.
Strong understanding of aseptic processing barrier technologies and contamination control.
Handson 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 crossfunctional teams.
Excellent communication and problemsolving 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
Required Experience:
Unclear Seniority
Employment Type
Contract
