Process Engineer
4 weeks ago
We are seeking an experienced Process Scientist to join our team at Oxford Global Resources. As a Process Scientist, you will play a key role in supporting the development and implementation of new manufacturing processes and technologies.
Key Responsibilities:- Lead and manage technical manufacturing projects, including improvement projects, new process introduction, and process validation.
- Support the GMT technical team in ensuring the transfer and scale-up of new processes and process robustness, including analytical testing.
- Develop and implement protocols and reports for technical trials, process validation, and regulatory support documentation.
- Identify and mitigate quality and manufacturing risks.
- Provide technical assessments for new and existing products.
- Support the process and analytical testing validation program at sites.
- Utilize six sigma tools to solve technical issues and improve manufacturing processes.
- Maintain strong communications with all levels of operating management and functional departments.
- Manage project budgets and maintain financial accountability to meet company goals.
- Take ownership of supporting the performance of manufacturing processes, including regular review of manufacturing data and process monitoring.
- MSc. degree in Biology, Microbiology, Bioscience Engineering, Biotechnology, Pharmacy, Chemistry, or Chemical Engineering.
- Pharma industry experience with a minimum of 5 years directly applicable job experience in vaccine/biopharmaceutical manufacturing support.
- Understanding of GMP and regulatory requirements for pharmaceutical manufacturing and development.
- Hands-on experience with Installation Qualification and Operational Qualification.
- Technical knowledge of analytical testing, cell culture, fermentation, aseptic vaccine drug product formulation, and fill finish, including equipment used.
- Project leader experience, preferably from the pharmaceutical or animal health industry.
- A successful track record of building strong teams and relationships.
- Ability to manage multiple competing priorities and meet timelines.
- Structured mindset with focus on quality.
- Proven ability to collaborate and communicate effectively across different scientific disciplines, functions, and levels.
- Fluency in English, both written and spoken.
- Existing right to work in Australia.
What We Offer:
- 12-month initial contract.
- Remuneration commensurate with experience.
- Full-time on-site position in Melbourne, Australia.
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