Engineer II, Process Engineering

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