Production support Expert at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Diploma with proven experience or degree
Knowledge of machinery, plants, and methodologies for drug production
In-depth knowledge of GMP regulations
Knowledge of issues related to aseptic production
Ability to use main information systems
Solid experience in QA/Production in pharmaceutical companies
Italian language
English language
Organizational skills
Observation skills
Relational and problem solving skills
Critical spirit
(Desirable) Previous involvement in manufacturing sterile and oral injectable medications

Responsibilities

Maintain pharmaceutical sterile injectables production compliance with US and EU GMP and company quality standards through prevention and intervention suggestions
Maintain continuous surveillance of the production lines for sterile forms (cleaning, blending, functionality, defects) to ensure adherence to current regulations and company quality benchmarks
Engage in outlining and orchestrating testing and validation procedures for machinery, ensuring alignment with current regulations and company quality criteria
Participate in self-audits and implement corrective actions to maintain regulatory compliance
Analyze and determine necessary actions to remove the causes of defects and complaints
Propose and participate in GMP training courses applicable to production activities based on control findings
Contribute to the issuance and revision of procedures and work sheets, ensuring their application during operational phases

Skills

Key technologies and capabilities for this role

GMPAseptic ProductionPharmaceutical ManufacturingQAProduction SupportValidationSelf-AuditsCorrective ActionsDefect AnalysisMachinery KnowledgeSterile InjectablesProduction Surveillance

Questions & Answers

Common questions about this position

What is the work arrangement or location for this role?

The position is based in Monza with standard office environmental conditions and a Mon-Fri work schedule.

What are the essential qualifications and skills required?

Essential requirements include a diploma with proven experience or degree, knowledge of machinery and methodologies for drug production, in-depth GMP regulations knowledge, aseptic production issues, ability to use information systems, solid QA/Production experience in pharma, Italian and English languages, plus organizational, observation, relational, problem-solving skills, and critical spirit.

What is the salary or compensation for this position?

This information is not specified in the job description.

What are desirable experiences for this role?

Previous involvement in manufacturing sterile and oral injectable medications is desirable.

What kind of team environment can I expect?

You will join an exceptionally driven team in an ambitious environment, working collaboratively to advance world-class pharmaceutical production.

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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