Biomedical Engineer jobs in Sydney NSW

Company Snapshot

EnGeneIC is a clinical-stage biotechnology company developing targeted nanocell therapeutics for cancer treatment. With a focus on innovation and precision medicine, EnGeneIC is expanding its production capabilities to support clinical and commercial manufacturing of its proprietary therapeutics.

Role Overview

EnGeneIC is seeking a Biomanufacturing Engineer or Biomedical Manufacturing Scientist to join its high-performing production team. This is a senior technical role—ideal for someone with GMP manufacturing experience who is capable of hands-on work and cross-functional collaboration. The successful candidate will play a key role in translating protocols into cGMP-compliant processes, supporting CDMO interactions, and contributing to the production of nanocell-based cancer therapeutics.

Core Responsibilities

• Participate in the manufacturing of EnGeneIC’s targeted nanocell therapeutics.
• Support CDMO tech transfer and process translation for cGMP production.
• Contribute to R&D and process development initiatives.
• Draft and maintain batch records, SOPs, and GMP documentation.
• Ensure compliance with TGA, FDA, and EU GMP standards.
• Perform QA checks on raw materials and support inventory control.
• Collaborate with QA, QC, and R&D teams to ensure manufacturing readiness.

Technical Profile

• Strong working knowledge of sterile manufacturing, cleanroom operations, and GMP documentation.
• Experience with fermentation, x-flow filtration and lyophilisation procedures.
• Familiarity with applied microbiology and contamination control.
• Proven ability to write SOPs and work instructions for sterile processes.
• Experience preparing documentation for GMP-regulated environments.

Candidate Attributes

• Self-motivated and dependable; thrives in a team-based, hands-on environment.
• Quick learner with a results-driven mindset and attention to detail.
• Excellent communication, documentation, and time management skills.
• Comfortable working independently and collaboratively across departments.

Qualifications

• Tertiary degree in Biological Engineering, Biotechnology, or related Life Sciences field.
• 5+ years of experience in biomanufacturing or GMP production preferred.
• Early-career candidates with strong technical aptitude and relevant experience will be considered.

Your application will include the following questions:

• Which of the following statements best describes your right to work in Australia?
• How many years' experience do you have as a biomedical engineer?
• Have you completed a qualification in biomedical engineering?
• Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?
• Do you hold Australian Security Clearance?
• Do you have a current Police Check (National Police Certificate) for employment?

Pay: $85,000.00 – $95,000.00 per year

Work Location: In person