QA Lead, Sterility at Thermo Fisher Scientific

Lengnau, Bern, Switzerland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceuticals, Life SciencesIndustries

Requirements

Bachelor’s or Master’s or equivalent experience in Microbiology, Biotechnology, Pharmacy, Chemical/Biomedical Engineering, or related field
5+ years in GMP biologics or sterile manufacturing with 2+ years in QA sterility/aseptic leadership
Profound understanding of aseptic processing, EM, validation of sterilization, and control of contamination in biologics
Strong experience with investigations (root cause analysis), CAPA, risk management, and audit interactions
Excellent communication, collaborator management, and decision-making under time-sensitive operations
Proficiency in maintaining sterility standards and hands-on aseptic supervision
Detailed problem solving and risk-based thinking
Continuous improvement approach

Responsibilities

Lead and uphold the Sterility Assurance Program and Contamination Control Strategy (CCS) for facility, utilities, equipment, materials, personnel, and processes
Lead risk assessments for aseptic processes, single-use systems, and critical interventions
Establish, assess, and authorize sterility assurance benchmarks; track, report, and intensify performance
Coordinate QA for aseptic processing for drug substance and drug product (e.g., upstream bioreactors, downstream filtration, UF/DF, DS)
Perform routine Gemba/walkthroughs and provide on-floor QA support during aseptic operations
Oversee planning, execution, and monitoring of environmental monitoring programs
Investigate EM excursions and drive CAPA efficiency and preventive actions
Provide QA oversight of sterilization methods, load configurations, biological indicators, and requalification schedules
Approve sterilization cycle development, validation protocols/reports, and change controls for single-use assemblies, filters, and aseptic connectors
Ensure validated cleaning and decontamination procedures for equipment and rooms (including sporicidal rotations)
Evaluate, assess, and endorse SOPs, validation protocols, master batch records, and QA standards linked to aseptic operations
Lead and respond to internal/external audits (e.g., FDA, EMA, MHRA, PIC/S); ensure readiness and remediation
Lead deviations, root cause analyses, CAPA, and efficiency checks for sterility-related issues (bioburden, endotoxin, EM)
Lead QA for changes impacting sterility (facility, equipment, single-use components, filters, cleaning agents, disinfectants)
Support tech transfers for new biomolecule products/processes ensuring sterility requirements are incorporated into process development and validation
Formulate and present aseptic behavior training, gowning certifications, and programs highlighting proficiency in sterility assurance
Mentor operations and QA staff to reinforce contamination control culture and right-first-time behaviors

Skills

Key technologies and capabilities for this role

Sterility AssuranceContamination Control StrategyAseptic ProcessingRisk AssessmentsEnvironmental MonitoringCAPASterilization ValidationValidation ProtocolsSOPsBiologics ManufacturingGemba WalksSingle-Use Systems

Questions & Answers

Common questions about this position

What qualifications are required for the QA Lead, Sterility position?

A Bachelor’s, Master’s, or equivalent experience in Microbiology, Biotechnology, Pharmacy, Chemical/Biomedical Engineering, or related field is required, along with 5+ years of relevant experience.

Is this a remote position, or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the work environment look like for this position?

The role involves working in a cleanroom environment with restrictions such as no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair, as well as office work, and includes routine Gemba/walkthroughs and on-floor support during aseptic operations.

What experience makes a strong candidate for this QA Lead role?

Strong candidates will have a degree in Microbiology, Biotechnology, or related fields with 5+ years of experience, plus expertise in sterility assurance, contamination control, aseptic processing, environmental monitoring, and leading audits, risk assessments, and CAPAs.

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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