Thermo Fisher Scientific Senior Process Engineer, Downstream Technology Transfer in St. Louis, Missouri
The Sr. Process Engineer is an expert in his/her field of expertise (downstream processing / purification) and is regarded as such within Biologics. The Sr. Process Engineer provides technological input in the prospecting phase and in running customer programs. He/She also contributes to defining and shaping Thermo Fisher Scientific Biologics’ and Thermo Fisher Scientific’s own technology programs. He/She is the linking pin between the Operations department and the Process Development (PD) department, responsible for the sound technology transfer.
The Sr. Process 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 working in close collaboration with supervisors, other Engineers, line management and (senior) scientists from PD and QA (compliance) managers. All activities are executed in projects [technology (Operational Excellence), Customer projects]. Each project is unique and teamwork with representatives of various departments and disciplines is essential for success.
The primary responsibilities of the Sr. Process Engineer may encompass the following tasks at a minimum:
Represent Tech Transfer (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 agreed upon timelines.
Supervise others 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.
- Bachelors degree in Biological Sciences or Chemical Engineering required. Masters degree preferred.
8+ years of experience in Bio / Pharma industry (protein purification / Downstream exp)
Experience in operations and GMPs are required.
Experience within the Biotech industry, including an understanding of the regulatory requirements.
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.
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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