Process & Cleaning Validation Specialist at Thermo Fisher Scientific

Monza, Lombardy, Italy

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries

Requirements

  • Degree in Pharmacy, Chemistry, Biotechnology, Biology, similar scientific degrees or consolidated experience
  • Previous experience in validation is helpful
  • Proficient English (both written and spoken)
  • IT knowledge: Company IT systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office tools
  • Personal skills: Excellent interpersonal skills, proactivity, ability to work in a team

Responsibilities

  • Issuing of validation documents relating to the manufacturing processes or cleaning procedures that must be validated, in order to acquire information necessary for the execution of the validation activities and the drafting of the validation reports, in compliance with the company procedures
  • Drafting technical documentation
  • Participate in the project teams discussing technical aspects of the validation strategy to be submitted to the regulatory authorities
  • Write technical validation documentation, in compliance with corporate procedures
  • Support the execution of operational activities from a technical point of view
  • Review the data generated by the validation activities and their analysis, in compliance with the protocols and company procedures

Skills

Key technologies and capabilities for this role

GMPFDAEMAProcess ValidationCleaning ValidationPMXLIMSTrackwiseMinitabMicrosoft Office

Questions & Answers

Common questions about this position

What qualifications and experience are required for this role?

A degree in Pharmacy, Chemistry, Biotechnology, Biology, or similar scientific fields is required, or consolidated experience; previous experience in validation is helpful; proficient English (written and spoken) is needed; IT knowledge of company systems (PMX, LIMS, Trackwise, Minitab) and Microsoft Office; excellent interpersonal skills, proactivity, and teamwork ability.

What is the work schedule and location for this position?

This is a full-time position with a standard Monday-Friday schedule in an office environment.

What are the company's core values?

The company shares values of Integrity, Intensity, Innovation, and Involvement, with a team of 100,000+ colleagues working together to accelerate research and support patients.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What makes a strong candidate for this position?

Candidates with a relevant scientific degree or experience, prior validation experience, proficiency in English and specified IT systems, plus strong interpersonal skills, proactivity, and teamwork abilities 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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