Thermo Fisher Scientific Senior Process Engineer, Upstream Technology Transfer in St. Louis, Missouri
The Senior Process Engineer is an expert in his/her field of expertise (cell culture processing) and is regarded as such within Biologics. The Senior Process Engineer provides technological input in the prospecting phase and in running customer programs. They also contribute to defining and shaping the company’s own technology programs. They are also the linking pin between the Operations department and the Process Development (PD) department, and responsible for the sound technology transfer.
The Senior Tech Transfer Engineer is part of the BioProcess Sciences (BPS) organization and is responsible for the technological quality and progress during the implementation and execution of the customer and technology projects within the Operations department. This role will work in close collaboration with supervisors, other engineers, line management, scientists from PD and QA compliance managers. These activities are executed in projects and each project is unique, requiring teamwork with representatives of various departments and disciplines for success.
The primary responsibilities of the Senior TT Engineer may encompass the following tasks at a minimum:
Represent TT in Internal and Core Team meetings and make sound evidence-based contributions.
Interface with customers in team meetings, one-on-one technical discussions, and in person.
Generate the process flow diagrams (PFD) for all programs.
Fit the PD established or Customer process and define methodologies for conducting unit operations at the manufacturing scale and document those procedures via template (non-process specific) PFD, SOPs and job aids.
Assist with the generation of good faith estimates and bill of materials (BOMs) for all client programs.
Complete documentation for supplier material qualification (SMQ) process in accordance with current SOPs.
Draft or oversee the drafting of Master Batch Records.
Review and comment on GMP and administrative documentation as appropriate:, SOP, Tech Transfer Protocols, MBR/MFRs, PFDs, Experimental Protocols, Process Qualification Protocols, IPC strategy, Quality Risk Assessments, FMEA/HACCP, RCA, CAPAs, Events, Investigations, Campaign Summary Reports, Reconciliation, etc.
Identify manufacturing needs with respect to documentation/systems and deliver them to the agreed upon timelines.
Supervise others directly or indirectly who are generating GMP documentation and PFDs.
Generate new GMP documentation and templates (MBRs, SOPs & Reports) and PFDs with minimal assistance from manager.
Work with PD and customer to design in manufacturability of each new customer process.
Assist with updating PD on operational requirements and reviewing of associated documentation.
Help reviewing incoming raw materials for alignment with platform. Responsible for identifying improvement to TT system having a high, intermediate, and moderate complexity
Able to identify strategic equipment needs and provide expert advice on the specifications for use either in PD or GMP. Interfacing with clients and customers on assigned projects.
Bachelors or Masters Degree in the fields of Life Science preferably in Bio-Chemical Engineering field with ≥ 8 years of experience in the industry.
PhD with ≥ 4 years of industry experience in a relevant field.
8+ years of experience in Bio / Pharma industry (cell culture / Upstream exp)
Experience in operations and GMPs is required.
Experience within the Biotech industry, including an understanding of the regulatory requirements.
Equivalent combinations of education, training and relevant work experience may be considered.
Detailed knowledge of GMP and other pharmaceutical regulations from FDA, EU, ICH and PIC 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.
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.