Process Engineer II at Thermo Fisher Scientific

Lenexa, Kansas, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Food Testing, Clinical DiagnosticsIndustries

Requirements

BS in Engineering, Microbiology, or other STEM degree required. Advanced degree a plus
Analytical and data analysis skills with Excel and statistical software
Technical Writing
Experience with ISO 9001 and ISO 13485
Excellent communication skills, both written and verbal
Ability to handle and plan multiple projects
Outgoing and collaborative in nature
Detail Oriented
Six Sigma or Lean Manufacturing
Ability to Work on Manufacturing Floor
2+ years technical experience that includes process engineering, process development, project management
1-5 years experience within the medical device or pharmaceutical industry
Preferred: 2+ years direct microbiology experience within the medical device or pharmaceutical industry

Responsibilities

Investigate non-conforming products and track results using Excel spreadsheets (Pivot Tables, PowerBI) and identify trends for RCA. Perform historical batch and literature reviews to resolve product performance (engineering, microbiology, chemistry)
Drive special projects to drive business growth, cost savings, and profitability
Develop and improve processing methods (aseptic and non-aseptic dispensing, dry blending, mixing, cooling, solubility, freeze drying, dispensing, thermal processing, formulation)
Author technical protocols and lead engineering studies
Operate industrial processing equipment (boiling tanks, blenders, dispensers, labellers, etc.) to test processes, investigate issues, and build work instructions
Investigate process capability using Statistical DOE, Process Control, GR&R, Regression, and ANOVA (MiniTab)
Author and lead changes within QMS; deviation investigations (planned and unplanned), CAPAs, customer complaints, SOPs, Batch Manufacturing Records, etc
Strong collaboration skills, working with department supervisors and other departments using verbal and written communication

Skills

Excel

Pivot Tables

PowerBI

Root Cause Analysis

DOE

GR&R

ANOVA

Regression

Minitab

Aseptic Processing

Dry Blending

Mixing

Freeze Drying

GMP

Cleanroom

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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