BSA/ Validation - Instrument software at Thermo Fisher Scientific

Zaventem, Flanders, Belgium

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, Scientific InstrumentsIndustries

Requirements

Perform system risk assessments
Create system validation test cases
Create testing summary reports
Create system diagrams
Familiar with EMA and other regulatory guidelines

Responsibilities

Perform system risk assessments
Create system validation test cases
Create testing summary reports
Create system diagrams

Skills

Key technologies and capabilities for this role

System Risk AssessmentSystem ValidationTest CasesValidation ReportsSystem DiagramsEMA GuidelinesRegulatory ComplianceInstrument Software

Questions & Answers

Common questions about this position

What is the work schedule for this position?

The position is full-time with a standard Monday-Friday schedule.

What are the required skills for this BSA/Validation role?

Required skills include performing system risk assessments, creating system validation test cases and testing summary reports, creating system diagrams, and familiarity with EMA and other regulatory guidelines.

What is the salary range for this position?

This information is not specified in the job description.

What are the environmental conditions for this job?

The role is based in an office environment.

What makes a strong candidate for this role?

Candidates with hands-on experience in system risk assessments, validation test cases, system diagrams, and knowledge of EMA regulatory guidelines will stand out.

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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