Staff QA Engineer at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

BS/BA in a scientific or related field required, preferably in Biology/Chemistry or Engineering. Advanced degree preferred
5+ years of experience in Quality and/or Validation
7+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred
Proven ability to lead and mentor multi-functional teams
Strong leadership skills and ability to work within a matrix organization
Ability to support and lead multi-functional and multi-site initiatives involving integration
Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below
Ability to prioritize, align and simplify, demonstrate enthusiasm, take accountability and drive for results
In-depth knowledge of cGMPs, technical writing, data management collection, and analysis
Exceptional interpersonal skills, including teamwork, facilitation, and negotiation
Ability to work independently, with a pro-active mentality to mitigate risk

Responsibilities

Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment
Provide strategic quality oversight of facility and equipment commissioning and other activities
Review and approve: Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports
Review and approve validation related deviations and discrepancies
Review and approve Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports
Lead QA support for risk assessment, FMEA, and change controls governing validation related activity
Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations
Develop and maintain a safety and quality culture
Mentor and train junior QA Engineers
Drive continuous improvement initiatives in validation processes

Skills

cGMP

Process Validation

Cleaning Validation

Computer System Validation

FMEA

Risk Assessment

Change Control

Validation Protocols

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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