Engineer III, QA at Thermo Fisher Scientific

Allentown, Pennsylvania, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotech, Clinical TrialsIndustries

Requirements

Bachelor's degree in engineering or science fields
4-5 years in Qualification and Validation in pharma or medical device environment
Minimum of 2 years in the pharmaceutical/related regulated industry
Experience with process validation in Quality Systems
Experience in Risk Assessment
Familiarity with or experience in Microsoft Word, Excel, PowerPoint, TrackWise, and Calibration/PM Systems
Detail oriented to detect errors or deficiencies in validation and qualification documentation
Utmost integrity and personal responsibility for regulatory compliance
Good written and verbal communication skills
Detailed understanding of regulatory documentation requirements
Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products
Ability to work independently
Proficiency in skills (inferred from context, e.g., related tools/systems)

Responsibilities

Quality approval for equipment validations (IQ, OQ, PQ)
Conduct risk assessments (FMEA)
Alarm management (temperature, humidity, differential pressure)
Oversight of Maximo work order system (calibration, corrective maintenance)
Make decisions based on sound quality/compliance principles and GMP Regulations
Apply Good Manufacturing Principles in all areas of responsibility
Demonstrate and promote the company vision
Review impact analysis of changes to facilities and equipment
Review and approve GMP documents to ensure compliance with internal and regulatory standards
Advise management of issues identified during qualification activities and recommend actions
Drive continuous improvement to the site’s equipment and facilities qualification/validation program
Ensure compliance to the site calibration program
Supervise the preventative maintenance program
Facilitate, participate, and approve Risk Assessments
Conduct all activities in a safe and efficient manner
Perform other duties as assigned to meet business/compliance needs

Skills

FMEA

alarm management

Maximo

calibration

corrective maintenance

GMP

PPE

risk assessment

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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