Thermo Fisher Scientific Sr. Process Engineer, Upstream Technology Transfer in St. Louis, Missouri
The Senior Process Engineer is an expert in his/her field of expertise (upstream 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.
The primary responsibilities of a Senior Process Engineer are:
May supervise scientists and engineers directly or indirectly
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.
Interface with customers on assigned projects, for technical discussions and decisions.
Represent Tech Transfer in Internal and Customer meetings and make sound evidence-based contributions.
Identify improvement to TT system having a high, intermediate, and moderate complexity
Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs
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)
Implement changes to equipment and processes under minimal direction.
Identify strategic equipment needs and provide expert advice on the specifications for use either in Process Development or GMP manufacturing
Bachelors or Master’s Degree in a Biological Sciences preferably in Bio/Chemical Engineering field with ≥ 10 years of experience in the Biologics industry.
PhD with ≥ 6 years experience in in the Biologics industry.
Other Job Requirements:
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 and PICs guidelines. Demonstrated success in managing multiple projects of high complexity.
Expert knowledge of process development, process scale-up and cGMP manufacturing.
Knowledge of the current regulatory requirements.
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.
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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.