Senior QA Engineer
Flock Safety$140,000 - $213,000/year
Full Time
Senior (5 to 8 years)
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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work location for this QA Engineer role?
The role reports to the Allentown, PA site and is part of the Clinical Trials Division (CTD).
What education is required for this position?
A Bachelor's degree in engineering or science fields is required.
What are the main responsibilities of this QA Engineer role?
Responsibilities include quality approval for equipment validations (IQ,OQ,PQ), risk assessments (FMEA), alarm management, oversight of Maximo work order system, reviewing GMP documents, and driving continuous improvement in qualification programs.
What is the company mission and culture like?
Thermo Fisher Scientific focuses on meaningful work that makes a positive global impact, enabling customers to make the world healthier, cleaner, and safer, with a strong emphasis on 'There is a Patient Waiting' in the Clinical Trials Division.
What makes a strong candidate for this Engineer III, QA position?
Strong candidates will have a Bachelor's degree in engineering or science, experience applying GMP principles, conducting risk assessments, equipment validations, and ensuring compliance with regulations.
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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