Job Description Position Summary: When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
This growth role is available in Manufacturing Science & Technology's (MS&T's) Process Validation department at Thermo Fisher Scientific's St. Louis facility.
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, analyze 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.
This role will not have direct reports, however, mentoring/ advisory relationship to junior level scientists/ engineers is expected. This position will have a degree of supervision of others related to specific project work. This role is expected to require a low degree of oversight from management, and the exercise of a high degree of autonomy is expected. Essential Functions
- Represent Process Validation on project teams and interface with customer technical and Quality representatives
- Independently manage commercialization projects with respect to PV with minimal oversight
- Write and execute validation documents for processes and unit operations following the requirements of project specific Process Validation Plans, site and company policies, and departmental SOP's.
- Compile and analyze manufacturing data, author/review/approve validation protocols and summary reports.
- Perform the technical review on other site documents such as deviations, change controls.
- 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.
- Provide data, analyses, write-ups, reviews, and other input to annual product reviews (APR)
- Actively drive improvements for PV, OPS, and MTS practices and procedures.
- Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and lead multidisciplinary teams in developing and implementing solutions.
- Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers.
- Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results.
- Department leaders and individual contributors
- Project leads
- Other business units
Other Job Requirements:
- Bachelor's degree in Chemical or Mechanical Engineering or Statistics. Other engineering or science degree considered based on relevant work experience
- 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)
- Strong written and oral communication skills.
- Demonstrates a solid foundation in general scientific practices, principals and concepts
- Ability to work both independently and in a team environment
- In depth knowledge of current Good Manufacturing Practices and US/EU regulations.
- Ability to self-motivate, prioritize work and time.
- Proficient in Microsoft Word and Excel.
- 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.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission--enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.