04 May, 2021

Process Engineer

  • Thermo Fisher Scientific
  • Millersburg, PA, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Thermo Fisher Scientific is a biotechnology product development company located in Waltham, MA. The company's premier brands are Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services. Generating more than $24 billion in annual revenue, Thermo Fisher Scientific is a significant player in the research, healthcare, industrial and applied markets, with a range of customer touch points that is hard to match. The company offers various career opportunities at 600+ sites across the Americas, APAC and EMEA regions in an inclusive, global culture that values diverse talent. The core activity being scientific R&D, there are also opportunities in Operations, Quality & Regulatory, IT, Sales and more. As an employee, you can count on ample opportunities to grow your career as well as a comprehensive total rewards package which includes a competitive base pay, medical and dental plans, wellness programs, company-paid insurance, savings and spending accounts, competitive 401(k) and more.

 

JOB DESCRIPTION

When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

 

Position Summary

This position is under the direction of the Process Engineering Manager and includes responsibilities related to designing, executing and documenting validation engineering activities as well as to develop and improve processes to drive productivity, capacity, cost reduction and efficiency.

 

Key Responsibilities:

  • Follow all safety and current Good Manufacturing (cGMP) requirements within the plant
  • Develop and execute 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, execute, 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
  • Execute laboratory and measurement-based studies and write technical reports summarizing results with emphasis on technical rigor
  • Drive process improvement opportunities and/or corrective actions to increase yield, maximize 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
  • 2+ years of experience
  • Proficient in MS Office
  • Excellent technical aptitude
  • Statistical knowledge
  • Effective communication skills both written and verbal
  • Positive attitude with ability to work independently and as a member of a cross-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

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have 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 Now