Thermo Fisher Scientific Senior Process Engineer, Downstream Manufacturing Technical Support in St. Louis, Missouri

Job Description

Position Summary:

This growth role is available in Manufacturing Technical Support (MTS) at our St. Louis facility.

This position is responsible for being the primary technical support person for commercial manufacturing processes, investigations of the most challenging technical level, and plays a central role in resolving key process developments. This individual may also lead a team of several junior process engineers to complete similar work across late phase and commercial processes at the facility.

This person has developed a core competency in supporting processes for GMP scale production during late phase clinical runs through PPQ campaigns and commercial campaigns, by conducting manufacturing process technical investigations, providing product impact technical assessments, and providing technical advisement on process changes . The individual may provide immediate supervision or assign tasks to a unit or group of employees.

The MTS Engineer is part of the Bioprocess Sciences (BPS) organization. This role will work in close collaboration with customers, supervisors and technicians in the Operations department, QA, other Engineers, line management, and scientists in PD. These activities are executed in projects, and involve teamwork with representatives of various to ensure project success.

Essential Functions

The primary responsibilities of an MTS Senior Process Engineer are:

  • May supervise scientists and engineers directly or indirectly

  • Perform all functions associated with process support, e.g. develop process technical understanding, perform gap analysis / FMEA, generate process models, author changes to and review Process Descriptions and Batch Records

  • Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes). Actively drive improvements for MTS practices and procedures.

  • Provide guidance on process transfer and support activities to junior members of the team.

  • Assess major deviations for impact to product quality.

  • Identify potential root causes using a systematic approach. Exhibit expertise in use/application of a variety of problem solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. Resolve complex problems and leads multidisciplinary teams in developing and implementing solutions.

  • Perform and be able to understand and interpret multiple types of data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications where appropriate.

  • Author and review process descriptions, definitive formulations, batch records, raw material listings, change controls independently and author/review/modify the corresponding templates. Demonstrate ability to identify and create new documents that would aid in process transfer or support activities. Identify process changes and assess change controls for impact of process/equipment or procedural changes that can affect both process performance and product quality. Support documentation preparation for regulatory purposes.

  • Represent MTS on project teams and interface with customer technical and Quality representatives. Represent MTS on internal teams (e.g. Deviation and Run Daily Management System meetings).

  • Participate in Customer and Regulatory Audits. Regularly interact with site and global leadership on matters concerning several functional areas and/or customers.

Frequent Contacts:

Internal

  • Department leaders and individual contributors

  • Project leads

  • Site leadership team

External

  • Vendors

  • Customers

  • Other business units

Minimum Requirements/Qualifications:

  • Degree in Bio/Chemical Engineering or Biological Sciences field.

  • A Bachelor’s degree plus 12 years of relevant experience, Master’s degree plus 10 years of relevant experience, PhD with a minimum of 8 years of relevant experience.

  • Extensive biotech industry experience in process scale up and commercial scale manufacturing operations

  • Advanced knowledge of cell biology, protein structure, scale up, chromatography, UF/DF, virus filtration and knowledge of statistical data analysis. In depth knowledge of large scale manufacturing and current Good Manufacturing Practices

Other Job Requirements:

  • Disposable technology experience preferred.

  • Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment

  • Detailed knowledge of GMP and other pharmaceutical regulations from FDA, EU, ICH guidelines. Demonstrated success in managing multiple projects of high complexity.

  • Expert knowledge of process development, process scale-up and cGMP manufacturing.

  • Proven success in conducting engineering tasks of high complexity.

  • Ability to self-motivate, prioritize work and time. Able to manage multiple concurrent technical projects and timelines using project management tools (Microsoft Project, etc.)

  • Soft skills and proven success in effectively interacting with customers and positively influencing them for concurrence are preferred.

  • Proven leadership skills that gets results through others are important characteristics of a successful candidate.

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 at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility 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.