Job Description

Senior Process Engineer / Sr. Technical Transfer Engineer

The Senior Process Engineer / Sr. Technical Transfer Engineer is an expert in his/her field of expertise
(downstream processing) and is regarded as such within Biologics (experienced with antibody
purification is a plus). The Senior Process Engineer / Sr. Technical Transfer 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.

The Senior Process Engineer / Sr. Technical Transfer Engineer is responsible for the technological quality
and progress during the implementation and execution of the customer and technology projects within
the Manufacturing and Science Technology 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.

What will you do?

• The primary responsibilities of the Senior Process Engineer / Sr. Technical Transfer Engineer may encompass the following tasks at a minimum:
• Represent technical transfer 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.
• 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.
• 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.

Experience, Knowledge, Skills, Abilities

• Experience in operations and GMPs is required.
• Experience within the Biotech industry and especially downstream processing of biologics (chromatography, filtration, UFDF), 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 of biologics.
• 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.

How will you get here?

• Bachelor's degree required in the fields of Life Science preferably in Bio-Chemical Engineering field with 10 years of experience in the industry.
• Master's Degree in the fields of Life Science preferably in Bio-Chemical Engineering field with 7 years of experience in the industry.
• PhD with 4 years of industry experience in a relevant field