Thermo Fisher Scientific Senior Process Engineer, Downstream Technology Transfer in St. Louis, Missouri

Job Description

Sr. Process Engineer (Downstream Technology Transfer)

Requisition ID: 76265BR

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.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

The Downstream Senior Process Engineer is an expert in his/her field of expertise (downstream processing) and is regarded as such within the Pharma Sciences Group of Thermo Fisher Scientific. The Tech Transfer Engineer provides technological input in the transfer and development of a process and is the technical owner while running customer programs in clinical manufacturing. He/She also contributes to defining and shaping Thermo Fisher Scientific’s own technology programs. The Senior Process 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.

What will you do?

  • Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include cell expansion and bioreactor operation.

  • Represent Tech Transfer in Internal and Customer meetings and make sound evidence-based contributions.

  • Document procedures via PFDs, Standard Operation Procedures, and Job Aids.

  • Draft and own Manufacturing Batch Records ensuring the process is technically accurate and Designed for Manufacturing

  • Create a Bill of Materials (BOMs) for programs

  • Generate process flow diagrams (PFDs)

  • Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs

  • Implement changes to equipment and processes under a high level of direction.

  • Identify improvement to TT system having a high, intermediate, and moderate complexity

  • Identify strategic equipment needs and provide expert advice on the specifications for use either in Process Development or GMP manufacturing

  • Interface with customers on assigned projects

  • May supervise scientists and engineers directly or indirectly

How will you get here?

Education

  • Bachelors or Master Degree in a Biological Sciences preferably in Bio/Chemical Engineering field minimally required. PhD highly preferred. with ≥ 10 years of experience in the Biologics industry.. PhD with ≥ 6 years experience in in the Biologics industry.

Experience

  • With PhD, at least 6 years of experience in the Biologics industry

  • With Bachelor’s or Master’s, at least 10 years of experience in the Biologics industry.

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

  • Demonstrated success in managing multiple projects of high complexity

  • Proven success in conducting engineering tasks of high complexity

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

Knowledge, Skills, Abilities

  • Detailed knowledge of GMP and other pharmaceutical regulations from FDA, EU, ICH, and PICs guidelines.

  • Knowledge of the current regulatory requirements.

  • Proven leadership skills that gets results through others.

  • Well organized and detailed oriented.

  • Excellent interpersonal, analytical/problem solving and communication skills.

  • Ability to manage multiple concurrent technical projects and timelines using project management tools (Microsoft Project, etc.)

  • Ability to self-motivate, prioritize work and time.

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

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.

Apply today! http://jobs.thermofisher.com

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.