Sterile Academy & Sterility Assurance Specialist - Fixed Term Contract at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology
At least 1-2 years of experience in the pharma/chemistry industry
Previous experience in the manufacturing of sterile medicinal products
Strong knowledge of aseptic processes, Sterility Assurance concepts, and microbiological notions
Excellent written and oral communication skills with the ability to interact effectively with all levels of management and personnel at the operating unit level
Fluent understanding of Sterility Assurance guidelines
Proficient in spoken and written English and Italian
Strong problem-solving and stress management skills
Ability to prepare technical documentation
Attention to details and precision
Organizational and presentation skills

Responsibilities

Execute Sterile Academy training modules and related reports (classroom and digital training organization)
Collaborate with the QC Microbiological lab and Production teams to evaluate Environmental Monitoring data
Support the Sterility Assurance team in implementing the new Annex 1 guidelines, including conducting GAP assessments and FMEAs to evaluate the risk of microbial, pyrogen, and particulate contamination. Additionally, contribute to the development and implementation of the Contamination Control Strategy and CAPA plan
Evaluate Sterility Assurance topics related to new projects, such as new departments, manufacturing lines, and processes/products introduced
Provide support for Sterility Assurance deviations and participate in regular oversight activities in the production department to improve and promote a culture of Sterility Assurance

Skills

Key technologies and capabilities for this role

Sterility AssuranceEnvironmental MonitoringAnnex 1 guidelinesGAP assessmentsFMEAsContamination Control StrategyCAPAAseptic processesMicrobiologyPharma manufacturing

Questions & Answers

Common questions about this position

What is the duration of this contract position?

This is a 12 months fixed term contract.

Is this role remote or office-based?

The role is office-based with standard Monday-Friday schedule and office environmental conditions.

What qualifications and experience are required for this position?

A degree in Pharmacy, CTF, Biological Sciences, Chemistry, Industrial Chemistry, Chemical Engineering, or Biotechnology is required, along with at least 1-2 years of experience in the pharma/chemistry industry and previous experience in manufacturing sterile medicinal products. Strong knowledge of aseptic processes, Sterility Assurance concepts, and microbiological notions is also needed.

What is the company culture like at Thermo Fisher Scientific?

The company is committed to fostering an inclusive and diverse work environment, acts as an equal opportunity employer, and provides reasonable accommodations for individuals with disabilities.

What skills make a strong candidate for this role?

Strong candidates will have excellent communication skills in English and Italian, problem-solving abilities, attention to detail, and experience preparing technical documentation, along with fluency in Sterility Assurance guidelines.

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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