QC Section Head – Environmental Monitoring at Thermo Fisher Scientific

Swindon, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

PSG or equivalent experience
Career Band: 06, Career Track: Management
Experience leading a microbiology group in a sterile regulated setting (e.g., pharmaceutical products, cleanrooms)
Knowledge of Good Manufacturing Practices (GMP) and safety standards
Ability to manage a team of 11 microbiologists
Expertise in microbiology testing for batch releases, microbial identification, contamination control, and investigations
Experience with cleanroom quality compliance (microbial and particulate assessments), utilities management (e.g., compressed air systems), and cleanroom license training
Proficiency in QC deviations, CAPAs, change controls, batch release activities, and environmental monitoring qualification
Knowledge of biological indicators testing for sterile processing and decontamination systems
Expertise in qualification and validation of microbiology testing methods
Ability to provide high-level technical support, implement scientific proficiency, and lead global regulatory updates

Responsibilities

Lead the Environmental Monitoring QC department and coordinate a microbiology team of 11
Ensure cleanrooms comply with microbial and total particulate count assessments to maintain sterility
Supervise microbial identification of environmental isolates to support contamination control and investigations
Oversee utilities management and compressed air systems for compliance and reliability
Manage cleanroom license training to maintain staff competency and regulatory compliance
Facilitate attainment of section benchmarks, including QC deviations, CAPAs, change controls, and batch release activities
Lead environmental monitoring qualification for cleanrooms to ensure ongoing regulatory compliance
Support and coordinate testing of biological indicators for sterile processing and decontamination systems
Oversee qualification and validation of microbiology testing methods
Deliver high-level technical support and implement scientific proficiency in microbiology and quality units
Facilitate global regulatory updates and lead site implementation of new guidelines and processes
Manage department Key Performance Indicators (KPIs) to ensure targets are met on time
Conduct one-to-ones, performance reviews, and goal setting for team members
Collaborate with different business sectors to accomplish tasks meeting business, client, and customer requirements
Write and complete protocols and reports (e.g., URS)

Skills

Environmental Monitoring

Microbiology

GMP

Cleanroom Management

Microbial Identification

Contamination Control

Particulate Count Assessment

Utilities Management

Compressed Air Systems

Batch Release Testing

QC Supervision

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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