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 plantDevelop 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) activitiesCreate, complete, and document all validation activities within the plant-based systemUse Design of Experiments (DOE) to optimize critical process parameters of manufacturing systemsParticipate as critical team member on project teams to start-up new facilities, equipment or processesPerform trending and monitoring of critical quality attributes and critical process parameters to maintain product quality and control process driftData driven- champion the use of data visualization and analytical tools throughout the manufacturing environment including Statistical Process ControlDocument studies, changes and improvements throughout the Quality Management System in the form of CAPAs or other investigationsConduct laboratory and measurement-based studies and write technical reports to summarize your resultsDrive process improvement opportunities and/or corrective actions to increase yield, improve production capacity, reduce cost and decrease process variability while maintaining regulatory complianceSupport all aspects of engineering, manufacturing, and research and development as neededSelf-motivated with good problem solving, communication, coordination, and mentoring skills

Minimum Qualifications:

Bachelor’s degree in Engineering, Statistics, Technical or related fieldMinimum 2 years of experience in a manufacturing environmentProficient in MS OfficeExcellent technical curiosityStatistical knowledgeEffective communication skills both written and verbalPositive demeanor with ability to work independently and as a member of a multi-functional teamAbility to work in fast-paced results orientated environmentDesire to contribute to the business and its teamHighly organized and self-motivatedVery hands-on work ethicAbility to work flexible hours if needed

Preferred Requirements:

Experience in a manufacturing environmentExperience with validation engineering in a regulated environmentStandards knowledge including ISO9001 and ISO13485Statistical 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 teamsSix-Sigma knowledge/certification