Thermo Fisher Scientific

CSV/ MES Quality Validation

Thermo Fisher Scientific$75K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Advanced Degree plus 3 years or Bachelor's Degree plus 5 years in quality assurance in regulated industries
  • ASQ certifications (CQE, CQA) preferred
  • Strong knowledge of cGMP and ISO 13485/9001
  • Proficient in CAPA, change control, risk management, and quality systems
  • Experience with validation and qualification protocols

Responsibilities

  • Ensure quality excellence and regulatory compliance across manufacturing operations
  • Lead investigations and drive continuous improvement initiatives
  • Conduct risk assessments and manage CAPAs
  • Support audits and implement quality initiatives
  • Collaborate with internal teams and interface with external customers and regulators

Benefits

  • Competitive remuneration
  • Annual incentive plan bonus
  • Comprehensive healthcare coverage
  • Range of employee benefits
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

DESCRIPTION:
As a Quality Engineer III, you'll help ensure quality excellence and regulatory compliance across manufacturing operations. You'll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO compliance.

You'll work with multiple teams to resolve quality issues, conduct risk assessments, manage CAPAs, support audits, and implement quality initiatives. The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators. You'll help establish and maintain quality standards while supporting a culture of continuous improvement and compliance.

REQUIREMENTS:
• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech)
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
• ASQ certifications (CQE, CQA) desired
• Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
• Expertise in quality systems including:
• CAPA and deviation management
• Change control
• Risk management and FMEA
• Document control
• Internal/external auditing
• Advanced problem-solving and root cause analysis skills
• Excellent project management abilities
• Strong verbal and written communication skills
• Proficiency with quality management software and MS Office
• Experience with validation and qualification protocols
• Knowledge of statistical analysis and quality tools
• Ability to work both independently and collaboratively
• Strong attention to detail while maintaining broad perspective
• Excellent interpersonal skills for cross-functional collaboration
• May require up to 25% travel
• Additional language skills may be beneficial

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Other

Relocation assistance is not provided.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ

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