CSV Specialist at Thermo Fisher Scientific

Ferentino, Latium, Italy

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life SciencesIndustries

Requirements

Scientific degree preferred, but not required
1+ years of experience in CSV
Excellent communication and interpersonal skills reflecting a positive, professional, customer-centered organization
Ability to collaborate and interact with the project team
Excellent proficiency in personal computer applications such as Microsoft Outlook, Word, Excel, and PowerPoint
Propensity for teamwork

Responsibilities

Develop and lead strategic CSV projects
Explore new simplification opportunities
Participate in internal cross-functional team meetings to accomplish goals and commitments made to strategic customers
Communicate status and issues regularly
Provide oversight of computer system validation activities and projects for Thermo Fisher Scientific Ferentino Site
Implement validation strategy, adhering to domestic and international GMP regulations
Take ownership and oversight of validation activities
Incorporate continuous improvements
Participate in regulatory inspections
Build, review, approve, track, and present documents and procedures required for compliance with pharmaceutical regulations
Handle external consultants from the request for an offer to the completion of the work

Skills

Key technologies and capabilities for this role

CSVComputer System ValidationGMP regulationsValidation StrategyRegulatory ComplianceProject ManagementCross-functional CollaborationDocument Management

Questions & Answers

Common questions about this position

What experience is required for the CSV Specialist role?

At least 1+ years of experience in CSV is required.

What skills are needed for this position?

Candidates need excellent communication and interpersonal skills, ability to collaborate with project teams, and proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.

Is this a remote position or office-based?

This is an office-based role in office environmental conditions.

What is the work schedule for this job?

The work schedule is standard Monday through Friday.

What education is preferred for the CSV Specialist position?

A scientific degree is preferred but not required.

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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