Sterility Assurance Manager at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor of Science Degree in relevant area (e.g., Microbiology, Applied Biology, or similar)
5+ years of Microbiology experience (preferably in Micro Laboratory or Environmental Monitoring, ideally within a sterile pharmaceutical manufacturing facility)
Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site
Detailed knowledge of aseptic processing, with practical experience in an active aseptic manufacturing operation preferred
Knowledge of aseptic process simulations (media fills)
Experience with pharmaceutical industry technology, especially from a validation, technical, or laboratory role (useful)
Familiarity with U.S. FDA, EU Annex-1, and other regulations and guidance
Strong investigative skills, preferably familiar with Root Cause Analysis methods
Leadership and supervisory experience (helpful)
Expertise with audits and client-facing roles
Outstanding technical writing skills
Influencing skills
cGMP Compliance
Strong sense of diplomacy and assertiveness
Quality Judgement
Effective time management and prioritization skills
Very high degree of interpersonal skills
Outstanding attention to detail and organizational skills
Self-starter, mature, independent, conscientious; ability to work in a fast-paced environment under pressure, multi-task, results-oriented
Ability to maintain a high degree of confidentiality
Discretion and independent judgment
Ordinary ambulatory skills and physical coordination sufficient to move about office locations

Responsibilities

Define/own/maintain contamination control strategy for assigned areas
Define, oversee, and improve the Environmental Monitoring (EM) program
Oversee the Media Fill Program
Lead aseptic Comportment/Training/Oversight
Oversee sterilization processes
Implement and lead risk assessments and improvement programs against current and future expectations
Lead sophisticated investigations into issues impacting Sterility Assurance (e.g., adverse EM trends, media fill failures)
Review & approve Major/Critical deviations and change proposals with Sterility Assurance impact for assigned areas
Stay up to date with best approaches and share knowledge (10% of time dedicated)
Act as Subject Matter Expert (SME) with regulators/clients (key part of audits)
Act as SME for new product introduction and applicable capital projects (e.g., new lines/processes)
Implement standard methodology (e.g., ensure understanding/compliance with updated Annex 1, lead transition and risk assessments)
Represent site on the Sterile Working Group and facilitate harmonizing practices across sites
Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)
Follow all job-related safety and other training requirements

Skills

Contamination Control Strategy

Environmental Monitoring (EM)

Media Fill Program

Aseptic Comportment Training

Sterilization Processes

Risk Assessments

Deviation Investigations

Annex 1 Compliance

GMP

Regulatory Audits

Microbiological Auditing

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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