Thermo Fisher Scientific's Mission is to enable our customers to make the world healthier, cleaner, and safer, and the global coronavirus (COVID-19) outbreak is a powerful reminder of the importance of that Mission. In fact, Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. Our efforts have been particularly focused in supporting analysis of the virus, diagnosis, personal protection, and ultimately helping in the development of new therapeutics and vaccines.Job Title: Process Validation EngineerLocation: BrisbaneReporting To: Validation ManagerHow will you make an impact?
Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by TGA, FDA, EMA, and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented, and maintained.
This position is responsible for being the primary statistical process control data analyst and technical problem solver for processes entering the commercial production phase of their process lifecycle. This role may have other process validation responsibilities as assigned, but will primarily retrieve process data, analyse the data, look for positive and adverse trends, correlate the findings, solve technical issues as noted by the data analysis for process improvement/ refinement, and create written reports about the exercise.
This person has developed a core competency in process validation and processes from the GMP scale production during late phase clinical runs through PPQ campaigns, and commercial campaigns, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Technical Support engineers.Key Responsibilities:
How will you get here?Education
- Represent Process and Cleaning Validation on project teams and interface with Customer Technical and Quality Representatives
- Write and execute validation documents for processes and unit operations following the requirements of project specific Process and/or cleaning Validation Plans, site and company policies, and departmental SOP's.
- Compile and analyze manufacturing data, author/review/approve validation protocols and summary reports.
- Represents Process/Cleaning Validation on internal teams (e.g. Deviation, Changes, and project management meetings).
- Perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes).
- Make recommendations for process changes and sponsor these changes.
- Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers
Experience, Knowledge, Skills & Abilities
- Bachelor's degree in Chemical or Mechanical Engineering or Statistics. Other engineering or science degree considered based on relevant work experience
What's in it for you?
- 5+ years of Biotech industry experience in commercial scale manufacturing operations
- 4+ years of experience with large scale process validation and/or manufacturing support (mammalian process required)
- In depth knowledge of current Good Manufacturing Practices and US/EU regulations
- Knowledge of basic statistical analyses such as T-tests, F-tests, box-plots, understanding p values, etc. as well as control charting, Nelson's/Shewart's rules (or other statistical trending rules), etc.
- Basic knowledge of statistical analysis and familiarity with a mainstream statistical software analysis program such as SAS, Minitab, JMP, or Statistica as well as an intermediate knowledge of process validation principles and their application in biologics drug substance manufacturing
- Good communication skills
- Proficient in Microsoft Word and Excel.
- A competitive salary and performance related bonus structure
- Exposure to market leading cutting-edge technologies.
- Development opportunities as part of a rapidly growing global organization
At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner, and safer.