Are you looking for a new opportunity in process engineering? Are you interested in gaining experience in a new manufacturing site with a global animal health company? Don't hesitate, and apply today!
Job Description
As an experience process engineer, you will work alongside the GMT technical team to support new process introduction projects.
Responsibilities
- Responsible for leading, managing, and directing technical manufacturing projects - improvement projects, new process introduction, process and analytical validation
- Support the GMT technical team, whose main responsibility is to ensure transfer and scale-up of new processes and process robustness, including analytical testing
- Write protocols and reports for technical trial, process validation, regulatory support documentation
- Identify and mitigate quality and manufacturing risks
- Responsible for providing technical assessments, for new and existing products.
- Support the process and analytical testing validation program at sites
- Utilize six sigma tools to solve a variety of technical issues.
- Utilize data trending and analysis to detect issues
- Maintain strong communications with all levels of operating management, interacting with all functional departments
- Maintain strong communications with all internal functional support departments, ESQA, ES, EHS and Regulatory.
- Manage project budgets and maintains financial accountability to meet company goals
- Take ownership of supporting the performance of the manufacturing processes, including regular review of manufacturing data / process monitoring to ensure manufacturing remains in control of the processes
- Manage improvement processes for reducing scrap, leading cost improvements projects on manufacturing processes or analytical process
- Manage improvement process for improving material usage through process yield improvement projects
- Support with training/coaching of junior and new team members
- Support the site on product impact assessments or quality investigations, where required
- Promote green belt and black belt project completion and certification
- Committed to project delivering on time in budget
- Work with other team leaders on sharing of technical knowledge across the businesses supported by the team
- Manage the site administrative aspects of leading projects
- Follow mandatory training requirements.
- Work in a safe manner and in a safe environment
- Identify new technologies which may be used in Quality Control Laboratories and Manufacturing.
Requirements
- MSc degree in Biology/Microbiology, Bioscience Engineering, Biotechnology, Pharmacy, Chemistry or Chemical Engineering is required
- 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 level
- Fluency in English, both written and spoken
- Existing right to work in Australia
12 month initial contract.
Remuneration commensurate with experience.
Location: Melbourne, Australia | full-time on site
