Engineer II, Process Engineering Position Available In Wilson, Tennessee

Engineer II, Process Engineering
Location Lebanon, Tennessee, United States of America Job Id

R-01317505

Job Type Full time Category Operations Remote Fully Onsite
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
When you join us at Thermo Fisher Scientific, you’ll be part of a team that shares your passion for exploration and discovery! Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or improving their laboratories, we are here to support them.
Location / Division
Lebanon, TN / BioProduction Division
How will you make an impact?
This position is under the direction of the Process Engineering leader and includes responsibilities related to designing, implementing and documenting validation engineering activities as well as to develop and improve processes to drive productivity, capacity, cost reduction and efficiency.
What will you do?
Follow all safety and current Good Manufacturing (cGMP) requirements within the plant
Develop and implement Field Acceptance Testing (FAT) and Site Acceptance Testing (SAT) using User Requirement Specifications (URS)
Lead validation engineering activities including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities
Create, complete, and document all validation activities within the plant-based system
Use Design of Experiments (DOE) to optimize critical process parameters of manufacturing systems
Participate as critical team member on project teams to start-up new facilities, equipment or processes
Perform trending and monitoring of critical quality attributes and critical process parameters to maintain product quality and control process drift
Data driven- champion the use of data visualization and analytical tools throughout the manufacturing environment including Statistical Process Control
Document studies, changes and improvements throughout the Quality Management System in the form of CAPAs or other investigations
Conduct laboratory and measurement-based studies and write technical reports to summarize your results
Drive process improvement opportunities and/or corrective actions to increase yield, improve production capacity, reduce cost and decrease process variability while maintaining regulatory compliance
Support all aspects of engineering, manufacturing, and research and development as needed
Self-motivated with good problem solving, communication, coordination, and mentoring skills

Minimum Qualifications:

Bachelor’s degree in Engineering, Statistics, Technical or related field
Minimum 2 years of experience in a manufacturing environment
Proficient in MS Office
Excellent technical curiosity
Statistical knowledge
Effective communication skills both written and verbal
Positive demeanor with ability to work independently and as a member of a multi-functional team
Ability to work in fast-paced results orientated environment
Desire to contribute to the business and its team
Highly organized and self-motivated
Very hands-on work ethic
Ability to work flexible hours if needed

Preferred Requirements:

Experience in a manufacturing environment
Experience with validation engineering in a regulated environment
Standards knowledge including ISO9001 and

ISO13485

Statistical engineering skills (ANOVA, DOE, parametric, non-parametric tools, SPC, etc.) and software platforms (Minitab, JMP)
Mechanical engineering skills (SolidWorks, AutoCAD)
Ability to lead projects and teams
Six-Sigma knowledge/certification