Thermo Fisher Scientific

Quality Engineer, QA Validation

Thermo Fisher Scientific$75K — $95K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years in medical device industry
  • Expert in cGMP regulations and GAMP 5
  • Proficient with validation documentation and lifecycle processes
  • Strong background in computerized system validation
  • Project management experience across multiple validation projects
  • Excellent analytical, problem-solving, and technical writing skills
  • Effective communication and interpersonal abilities.

Responsibilities

  • Lead validation activities for critical systems and processes
  • Develop and implement validation strategies in a GMP environment
  • Collaborate with cross-functional teams for successful qualification
  • Maintain compliance and drive continuous improvement initiatives
  • Serve as a technical subject matter expert during audits
  • Mentor team members and support diverse validation projects
  • Ensure adherence to regulatory requirements throughout project lifecycle.

Benefits

  • Access to cutting-edge technology and systems
  • Opportunities for professional development and mentorship
  • Collaboration with cross-functional teams in a global environment
  • Engagement in meaningful work contributing to healthcare advancements
  • Work in a structured environment adhering to high safety and quality standards.
Full Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

DESCRIPTION:


Join our QA Validation team at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. As a Staff Validation Engineer, you'll lead validation activities for critical systems, equipment, and processes that enable the development and manufacturing of therapies.

Working in a GMP environment, you'll develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards. You'll collaborate with cross-functional teams to ensure the successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle.

Your expertise will be vital in maintaining compliance, driving continuous improvement, and serving as a technical subject matter expert during audits and investigations. You'll have opportunities to mentor team members while working on diverse projects ranging from new product introductions to complex system validations.

REQUIREMENTS:


  • 5 or more years of medical device experience
  • Expert knowledge of cGMP regulations, GAMP 5, 21 CFR Part 11, and international regulatory requirements
  • Strong experience with validation lifecycle documentation including risk assessments, validation plans, IQ/OQ/PQ protocols, and summary reports
  • Demonstrated expertise in computerized system validation and data integrity requirements
  • Experience with manufacturing equipment, utilities, and facility qualification
  • Proven project management skills and ability to lead multiple concurrent validation projects
  • Strong analytical and problem-solving capabilities
  • Excellence in technical writing and documentation
  • Strong communication and interpersonal skills
  • Ability to influence and coordinate activities across multiple departments
  • Proficiency with validation tools and standard office software
  • Experience mentoring validation staff
  • Physical ability to work in both office and manufacturing environments

EDUCATION:

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in validation experience in pharmaceutical/biotech manufacturing or related GMP environment
• Preferred Fields of Study: Engineering, Science, Biotechnology, or related technical field

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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