Senior Process Engineer, Downstream Technology Transfer
Company: Thermo Fisher Scientific
Location: Saint Louis
Posted on: November 23, 2021
When you're part of the team at Thermo Fisher Scientific, you'll
do important work, like helping customers in finding cures for
cancer, protecting the environment or making sure our food is safe.
Your work will have real-world impact, and you'll be supported in
achieving your career goals.How will you make an impact?The Senior
Process Engineer is an expert in his/her field of expertise
(downstream 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 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.What will you do?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
- 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
- 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.How
will you get here?
- Bachelor's degree required in the fields of Life Science
preferably in Bio-Chemical Engineering field
- Master's Degree in the fields of Life Science preferably in
Bio-Chemical Engineering field with ? 8 years of experience in the
- PhD with ? 4 years of industry experience in a relevant
fieldExperience, Knowledge, Skills, Abilities
- 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
- Knowledge of the current regulatory requirements.
- Proven success in conducting engineering tasks of high
- Soft skills and proven success in effectively interacting with
customers and positively influencing them for concurrence are
- Proven leadership skills that gets results through others are
important characteristics of a successful candidate.Physical
Requirements:Position requires ordinary ambulatory skills and
physical coordination sufficient to move about office locations;
ability to stand, walk, stoop, kneel, crouch periodically for
prolonged periods of time; manipulation (lift, carry, move) of
light to medium weights of 10-35 pounds; arm, hand and finger
dexterity, including ability to grasp and type for prolonged
periods of time; visual acuity to use a keyboard, computer monitor,
operate equipment, and read materials for prolonged periods of
time; ability to sit, reach with hands and arms, talk, and hear for
prolonged periods of time.Disclaimer:This job description is
intended to present the general content and requirements for the
performance of this job. The description is not to be construed as
an exhaustive statement of duties, responsibilities, or
requirements. Managers and supervisors may assign other duties as
needed.Nothing contained herein should be construed to create an
employment contract. Occasionally, required skills/experiences for
jobs are expressed in brief terms. Any language contained herein is
intended to fully comply with all obligations imposed by the
legislation of each country in which it operates, including the
implementation of the EU Equality Directive, in relation to the
recruitment and employment of its employees.At Thermo Fisher
Scientific, each one of our 75,000 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! 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.
Keywords: Thermo Fisher Scientific, St. Louis , Senior Process Engineer, Downstream Technology Transfer, Engineering , Saint Louis, Missouri
Didn't find what you're looking for? Search again!