Process Validation Group Scientist II
US - Illinois - Rockford Update time: October 21,2020
Job Description

Company Information

About Us

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Job Description

Internal Job Title (Profile) Name: Engineer/Scientist III, QC

Business Card Title: Process Validation Group Scientist II

Internal Job Code: OPS.QCOP.P06

Reports To: Senior Manager, Analytical Services Laboratory

Group: Life Science Solutions Group

Division: Bioscience Division (BID)

Business Structure: LSG Operations

Career Band: 06

Job Track: Professional

Finance Entity: BIRockford

Position Location: Rockford, IL

Number of Direct Reports: 0

Day/Shift (if applicable): Day

FLSA Status (Exempt/Non-Exempt): Exempt

Relocation (if applicable): No

Position Summary:

The individual will work with R&D, Marketing, Operations and Project Management on new product development, improvement projects for on market products, process validation, test method validation and raw material qualifications related to a limited group of product lines. This position requires participating on validation projects and completing tasks which align with departmental and company goals relative to safety, quality and cost. To be successful, the individual should demonstrate the 4I values of Integrity, Involvement, Innovation and Intensity.

Key Responsibilities – General for Process Validation Group Scientist II Position

  • Independently manage validation projects with limited scope and drive to completion.
  • Effectively manage activities associated with multiple, concurrent projects of limited scope and delivering results within assigned timelines.
  • Demonstrated process knowledge and technical expertise to support multiple departments (e.g. R&D, Large Volume and Custom, Organic Synthesis, Formulations, Biochemistry, Packaging, Mass Spectrometry, etc.).
  • Develop experimental plans to validate manufacturing processes and test methods.
  • Perform raw material qualifications
  • Ability to perform effective problem solving and root cause analysis.
  • Independently author validation plans and reports.
  • Ability to utilize Minitab to perform statistical analysis (e.g., Measurement System Analysis, capability analysis, control charts, basic hypothesis tests).
  • Support new product development teams with test method and process validation.
  • Demonstrated ability to perform basic Design of Experiment (DOE) and Measurement Systems Analysis (MSA) and analyze results. (e.g., 2 level, multiple factor screening DOE, design with center points).
  • Effectively communicate and document experimental results and related statistical analysis.

Minimum Requirements/Qualifications:

  • Education: Bachelors (B.S.) degree or M.S.
  • Experience: 4 years or 1 year
  • Basic understanding of statistics.
  • Fundamental knowledge and experience with statistical software (e.g., Design Expert, Minitab, etc.)
  • Knowledge and experience with equipment, manufacturing processes and test methods related to multiple production groups and/or product areas.
  • Ability to design complex experiments with limited guidance.
  • Minimum of 10 projects completed (New Product Introduction, productivity, material qualification, validation) involving multiple departments. This will include the completion of a minimum of 3 DOE and 3 MSA
    • 2-3 process validations
    • 2-3 test method validations
    • 2-3 raw material qualifications
  • Ability to lift up-to 20 pounds
  • Minimum business travel may be required (< 5% time)

  • Hazardous Waste Generation/Management: Associates in this position may, as part of their job activities, generate or manage hazardous waste as defined by the Illinois Environmental Protection Agency. Individuals in this position are required to receive initial hazardous waste training within the first 30 working days of assignment. The initial waste training shall include but not be limited to the following general categories: Identifying hazardous and solid waste, hazardous waste management, recycling, treatment and disposal, emergency preparedness, record keeping, pollution prevention and waste reduction. Following initial training the Associate in this position will receive annual refresher training in the same topic field as listed above. Associate should be comfortable working frequently with organics, including flammable solvents, strong acids / bases, potential biohazards (including raw animal serums), large scale bacterial cultures, and hazardous chemicals.

This position has not been approved for Relocation Assistance.

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